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Sunday, November 14, 2010

tablet, capsule and ORS production and quality control test

TABLETS SECTION


According to the Pharmacopeia of India “Pharmaceutical tablets are solid, flat, or biconvex discs, prepared by compressing a drug or a mixture of drugs, with without diluents. They vary in shape and differ greatly in size and weight, depending on the mount of medicinal substances and the intended mode of administration.”
The tablet types and abbreviation commonly employed include
Sugar Coating Tablets (SCT), Film Coated Tablets (FCT) Enteric Coated Tablets (ECT), Chocolate Coated Tablets (CCT), Multiple Compressed Tablets (MCT), Buccal or Sublingual Tablets (B/ST), Dispensing Tablets(DT), Hypodermic Tablets(HT).Time release, sustain release and Prolonged release tablets are designed to make medicament available to the body fluids in the controlled and desired manner and according to the manufacturer’s claim.
 Tablets are the solid dosage forms containing a medicament or mixtures of medicaments and excipient compressed or moulded into solid cylindrical shape having either flat or concave surfaces.

ADVANTAGES
1. Ease of accurate dosage.
2. Good physical and chemical stability.
3. Competitive unit production costs.
4. Release rate of the drug from tablet can be tailored to meet pharmacological requirements.

DISVANTAGES
1. Bioavailability problems because disintegration and dissolution is required before drug is available for absorption.
2. Solid having irritating effect on GIT mucosa posses problems for formulation into tablets.

QUALITY OF A GOOD TABLET:
1. They should be accurate and uniform in weight.
2. The drugs should be uniformly distributed throughout the tablets.
3. The size and shape should be reasonable for easy administration.
4. The tablets should not be too hard that it may not disintegrate in the stomach.
5. There should not be incompatibilities.
6. They should be chemically and physically stable during storage.
7. They should not break during transportation or crumble in the hands of the patient.
8. They should be attractive in appearance.
9. There should not be any manufacturing defects like cracking, chipping or discoloration.
10. After administration it should disintegrate readily.
11. They should be easy and economical in production.



TYPES OF TABLETS:

I. Compressed tablets
1) Coated tablets
a) Sugar coated tablets
b) Film coated tablets
c) Enteric coated tablets
2) Uncoated tablets
a) Multiple compressed tablets
i. Layered tablets
ii. Press coated tablets
b) Prolonged action tablets
c) Solution tablets
d) Effervescent
e) Lozenges
f) Chewable tablets
g) Buccal & sublingual tablets
h) Tablets suppositories pr Inserts.
II. Molded tablets or Tablets Triturates (TT)
1) Dispensing tablets
2) Hypodermic tablets

 Compressed tablets:
A. Oral tablets: - They are placed over the tongue and swallowed with a drink of water or any other suitable liquid takes place from there.
B. Chewable tablets: - These are the tablets, which are required to be broken or chewed in between the teeth before ingestion.
C. Buccal & sublingual tablets:- These tablets are required to be placed belong the tongue(sublingual) or in the sides of the cheeks (buccal) for the slow release of the medicament except in the nitroglycerin and mannitol, hexanitrate tablets which should dissolve in 1 to 2 min to produce immediate effect.
D. Lozenges tablets: - These tablets should not disintegrate in the oral cavity but should dissolve slowly in the mouth to produce continuous effect on the mucous membrane of the throat. In there formulation binding agents are added as to produce slow dissolution.
E. Soluble tablets: - These tablets are required to dissolve completely in the liquid to produce solution of definite concentration. The solution prepared by dissolving the soluble tablets may include mouthwashes, gargles, skin lotion, douches, antibiotics, and certain vitamins.
F. Effervescent tablets: - These tablets along with the active medicament contain other ingredients like SODIUM BICARBONATE, CITRIC ACID, TARTARIC ACID which react in the presence of water liberating carbon dioxide and producing effervescence leading to disintegration of tablet, thus hasten solution formation and increases the palatability. These tablets have the advantage over effervescent powders of being in the tablet dosage form.
G. Vaginal tablet (inserts): - Sometime vaginal suppositories or pessaries are prepared by compression, which are known as vaginal tablet. Antibiotics & steroids are formulated in this way.
H. Implants: - These are the small tablets meant for insertion under the skin by giving a small surgical cut into the skin which is stitched after the insertion of the tablet.
I. Enteric coated tablet: - These are the tablets which are required to be disintegrating in the intestine and not into the stomach.
J. Sustained release action tablets: - These are tablets which after oral administration release the drug at a desired time and prolong the effect of the medicament.
K. Sugar coated tablets: - These are the compressed tablets which are given a sugar coating to mask the objectionable taste and odor of the drug as well as to protect the substance from atmospheric conditions.
L. Film coated tablets: - These are the compressed tablet which are given a thin coating of water soluble material which protect the drug substances from the atmospheric condition.
M. Layered tablets: - These are the compressed tablets in which the granules of incompatible substances are compressed into two or more layers successively in the same tablet. Special tablet making machines are required for making layered tablets.
N. Press coated tablet: - In press coated tablets the granules of incompatible ingredient are compressed around the previously compressed tablet. These types of tablets can also be used for giving enteric coating & sustained release to the medicaments.




Compressed coated tablet Multilayered tablet Sugar coated tablet

TABLET COMPONENT

1) Active ingredient: - The dose of the drug to be administered has a profound effect on the design and formulation of a dosage form.
2) Diluents: - Diluents are fillers designed to make up the required bulk of the tablet when the drug dosage itself is inadequate. Such diluents should meet important criteria, including low cost, good tableting qualities and highly inert. Commonly used diluents are lactose, mannitol, sorbitol and dextrose.

DILUENTS COMMENT
Calcium carbonate Insoluble in water
Glucose Hygroscopic, reducing sugar
Calcium Hydrogen Phosphate Insoluble in water good flow property
Alpha –lactose
Inexpensive, inert and most common diluents
Mannitol
Popular for chewable tablets, freely soluble in water, cool taste
Sodium Carbonate
Freely soluble, used in solution tablet taste problem.
Sucrose
Hygroscopic, sweet taste used in lozenges on conjunction
Microcrystalline cellulose Excellent compression property , highly stable also disintegration property


DILUENTS TRADE NAME
MICROCRYSYALLINE CELLULOSE Arcel, Emcocel
MICROFINE CELLULOSE Elcema
MODIFIED STARCH Sta-Rx
DEXTRATES Emdex
SUCROSE DEXTRIN CO-PRECIPITATE Di – pace
CALCIUM HYDROGEN PHOSPHATE Emcopress
ANHYDROUS LACTOSE DCL
SPRAY DRIED LACTOSE Fast flow, zeparox

3) Binders & Granulating fluids: - These materials are added either in dry or in liquid form during wet granulation to form granules or to promote cohesive compacts for directly compressed tablets. The binders most commonly used are from natural sources, such as starch or cellulose derivatives. The substances mainly used as binders are acacia, gelatin, starch, tragacanth, liquid glucose, Polyvinyl pyrrolidine, cellulose derivative and alginate derivatives.

SUBSTANCE CONCENTRARION COMMENT
Acacia Mucilage Up to 20% Give very hard granules
Glucose Up to 50% Strong adhesive but hygroscopic
Gelatin 5-20% Used as warm solution H forms get on cooling , strong adhesive
Providone (PVP) 2-10% Soluble in water and some organic solvents, can be used for non aq. Granulation
Starch Mucilage 5-10% A common adhesive
Sucrose Up to 70% Hygroscopic, tablet hardness on storage
Tragacanth Mucilage Up to 20% Give hard granules

4) Disintegrant: - For most tablets, it is necessary to over come the cohesive strength introduced into the mass by compression. This process will by done by the disintegrates, by drawing water into the tablets, swelling and causing to burst apart. Such tablet fragment may be critical to the subsequent dissolution of the drug, leads to satisfactory bio- availability. The modern so-called “super” disintegrants which are added to tablets formulations at low levels can assist tablet disintegration by extra granular incorporation and intragranular incorporation. Commonly used disintegranting agents are starch and its derivatives, clay and microcrystalline cellulose.

SUBSTANCE CONCENTRARION (%) COMMENT/ TRADE NAME
Alginic Acid, Sod. Alginate 2-10%
Aluminium magnesium silicate Up to 10% Veegum
Carbon di oxide Created in-situ in effervescent tablet
Sodium carbony methyl cellulose or carmellose, sodium 1-2% Nymcel
Cationic Exchange Resins Up to 10% Amberlite IRP-88
Microcrystalline cellulose(MCC) Up to 10% Avicel
Starch 2-10% Potato and maize starch
Modified starch Starch 1500,sta-Rx1500
Sodium starch glycollate 10-10% Primojet Explotab
Cross carmellose sodium 2% Ac-Di-Si
crospovidone Cross linked povidone, poly plaschone

5) Glidants, Antiadherents and Lubricants: - Glidants are intended to promote flow of the tablet granulation or powder materials by reducing friction between the particles, e.g. talc, corn starch, colloidal silicates etc. Antiadherents have the purpose of reducing sticking or adhesion of any tablet granules or powder to the faces of the punches or to the die wall e. g. talc, magnesium stearate, starch derivatives etc.Lubricants are intended to reduce the tablet friction during tablet ejection between the walls of the tablets and the walls of the die cavity in which tablet is formed e.g. talc, stearic acid, magnesium stearate etc. The degree of film formation of magnesium stearate on the tablet has been studied by applying dissolution techniques and film coating tablet adhesion measurements.

GLIDANTS CONCENTRARION (%) COMMENT
Colloidal Silica 0.1-0.5 % Excellent glidant e. g. Aerosil, Cab-o-sil
Talc 1-2% Insoluble but not hydrophobic

6) Colors, Flavors, Sweeteners: - Colorants do not contribute to therapeutic activity, nor do they improve product bioavailability and stability. Two form of color have typically been used in the tablet preparation. These are FD & C and D & C dyes. Flavors are usually limited to chewable tablet or other tablets intended to dissolve in the mouth. Flavor oil at 0.5-0.75% conc. is added to tablet granules. The use of sweeteners are primarily limited to chewable tablets to evaluate or limit the use of sugar in the tablets e.g. saccharine, mannitol, aspartame etc.
.

SUBSTANCE CONCENTRATION IN TABLETS (%W/W) COMMENT, COMMERCIAL NAME
Fumiric Acid 5% Water soluble
Hydrogenated vegetable oil 0.5- 2.0% Lubritab
Liquid Paraffin Up to 2% Dispersion problem
Magnesium Lauryl Sulphate 1-2% Water soluble
Macragol 4000 & 6000 2-5% Water soluble
Sodium Benzoate 5% Water soluble, taste problems
Sodium lauryl sulphate 0.5-5% Wetting agent often used in conjuction with steaartes
Sodium Stearyl Fumarate 1-2% Soluble in hot water , Pruv
Stearates,Calcium Magnesium Stearic Acid strengt025-1.0%h Very effective lubricants, prolong disintegration time belt, crushing strength

 METHOD OF TABLET PREPRATION:-
The manufacture of granulation for tablet compression may follow one or a combination of three established methods.
a. DIRECT COMPRESSION METHOD: - The methods consist of compressing tablets directly from powdered material without modifying the physical nature of the material itself. Crystalline substances like sodium chloride, sodium bromide, & potassium chloride which possess cohesive and flow properties that make direct compression possible. The vast majority of medicinal agents are rarely, so easy to tablet, however, in addition the compression of a single substance may produce tablets that do not disintegrate. Direct compression materials should posses good flow and compressibility and must be inert, tasteless, able to disintegrate and inexpensive.

b. DRY GRNULATION: - It is also known as” SLUGGING”, “DOUBLE COMPRESSION” OR “RECOMPRESSION” METHOD. It can be used when the tablet ingredient are sensitive to moisture or are unable to withstand elevated temperatures during drying. Under this circumstances, this method provided the tablet ingredients have sufficient inherent binding or cohesive properties. Essential step in this method include weighing, mixing, slugging, dry screening, lubrication & compression. Binders such as spray dried powder or acacia may be added dry to the drug powder allowing formation of a cohesive slug. Lubricant materials are also added (not whole) to reduce powder adhesion to the punches and to facilitate ejection of intact slugs from the dies. Initially large tablets are made as slugs. The slugs are then comminuted through the desirable mesh screen either by hand or, at a large scale, through FITZPATRICK or a similar comminuting mill. Then the remaining lubricants are added to the granulation and after gently blending, the material is compressed into tablets. Examples of materials, which are by this method, are aspirin combination, acetophenetidin, thiamine hydrochloride, ascorbic acid, magnesium hydroxide and other antacid preparations.

c. WET GRANULATION: - This is the oldest and still most widely used method of tablet preparation. Studies on the influence of wet and dry granulation methods on the pore structure of lactose tablets proves wet granulation influence the pore structure over a wide range of tableting pressure while dry granulation influenced only when slugging pressure were high. The powder and mixed tablet constituent are converted to a moist coherent mass by wet screening. The process essentially involves a series of operation such as weighing, mixing, and granulation, screening the damp mass, drying, dry screening, lubrication and finally compression. However, as all of these operations are time bound, problem of reproducing uniform granulation from one lot to the next is the greatest disadvantage of this method. The active ingredients, diluent’s, disintegrant are mixed and blended well. Twin- shell blenders or ribbon blenders may be employed for large scale blending. The blended material is then shifted through a screen of suitable mesh to remove or break the lumps. The solution of binding agent is added to the powder with stirring till the mass attains the consistency of damp snow or brown sugar. A sigma blade mixer or Twin-shell blender may be used in pharmaceutical industry for this purpose. The damp mass is then forced through a 6 or 8 mesh screen. For large quantity FITZPATRICK comminuting mill is used. The granular material thus obtained is dried on trays in hot air oven or in a fluid bed dryer. After drying, the granulation is screened again, followed by compression.




















1)Wet Granulation (Schematic Diagram)




A Non GMP Machine for Tablet Compression Showing Various Parts










1. Upper Punch
2. Lower Punch
3. Station

4. Tarrot
• Upper

• Dye

5. Tablet Controller
• Callibre
• Tablet Dropper
6. Hydrolic Pressure
7. Oil pump Pressure
8. Dozer





The basic component or parts of Tablet Compression Machine
1. HOPPER for holding and feeding granules to be compressed
2. DIES that define the size and shape of the tablet.
3. PUNCHES for compressing the granulation within the dies.
4. CAM TRACKS for guiding the movement of the punches.
5. FEED FRAME which has several interconnected compartment, which spread the granulation over a wide area to provide time for the dies to fill.
6. ROLLER
7. TURET
8. BODY
9. DOSE CAPACITY ADJUST SCREW
10. TRAY
11. PULLY
12. VERM
13. PRESSURE REGULARTER
14. OIL BOXES
15. EXHAUST
16. LABLE HOLDER
17. Tablet machine output is affected by (NON GMP MODLE)
(a) No. of tooling stations
(b) No. of compression stations.
(c) Rotational speed of press.

 When the dozer is moved In left then tablet‘s thickness will be decrease and hardness will be increase. When the dozer is moved in right then weight will be increase. The max. Weight of 10 tablets must be 575-615mg only.

TYPES OF PUNCHES
There are 2 type of punches i.e. Moving & Non moving
• FB. Punch - Flat Beveled
• F.B.B.S.Punch –Flat Beveled bisect
• NC. Punch – Narrow concave
• SC. Punch – Shallow concave
• DC. Punch – deep concave
• Caplet punch

Length of punch----------------------------5.25” (Concave Punches)
Upper punch-----------------------------------1/2 “
Lower Punch----------------------------------1”- (it is present under the dies)










(Special Shaped Punches)

PUNCHES DIES

TABLETS COMPERSSION:- Various types of tablet compression machines so used are as follows:
1) Single punch machines
2) Multi punch machines
3) Rotatory machines
4) High speed rotatory machines
5) Multilayer rotatory machines
1) Single punch machines: - In these types of machines one set of dies and punches is fitted and only one tablet can be compressed at one time. They are used when small quantities of tablets are to be prepared. They may be hand operated or power operated and with these machine 60-90 tablets per minutes can be prepared.

2) The rotatory tablet machine: - The rotatory press has more than one set of tooling. The dies and corresponding pairs of punches are arranged around a circular rotating turret. Each individual dies with the lower punching its lowest position, passes under the powder bed which is contained in the feed frame, which in turn fed from the hopper. The die is completely filled under gravity, flow sometime being assisted by rotating fingers in the feed frame. The quantity of solid in the die is adjusted by weight controlling cam. These punches then pass upper punch to descend and the lower punch to rise. Thus the powder is actively compressed from both top and bottom faces. The top punch then withdraws and the lower punch ascends as it passes over an ejection cam.

GMP Model

TECHNICAL SPECIFICATION IN THE ROTATORY TABLET MACHINE
Number of station 10
Output per hour 9600 to 25200
Maximum tablet dia (mm) With D tooling ……….. 23
With B tooling………... 16
Maximum depth of fill (mm ) With D tooling ……….. 20
With B tolling …………17
Operation force 6 Tons
Details of Dies & Punches D tooling & B tooling both are used

3) Multi punch machines: - The construction and working of multi punches machines is exactly similar as that of hand operated single punch machines with difference that a number of dies varying from 2-12 are fitted with the steel frame having exactly the same no. of upper and lower punches. These types of machines are used when the size of tables is small and pressure can be adjusted easily.
4) Multilayer rotatory machines: - With multi layer rotatory tablet machines, tablets having one, two or three layers can be prepared by this method.

Some Important Things Will Be Noted Down While Starting Machine

If pressure increases thickness will be decreases.
If pressure decreases thickness will increases.
If capping is arise speed will be decrease as well as pressure will be decreases.
If sticking will be arise speed decreased and pressure increases.



GMP NONGMP
In tablet counting, tablets are counted 2, 4, 5, 6, 8….. on both side. In tablet counting tablets are counted in series i.e. 1, 2, 3, 4, 5, 6 ..… on both sides.

Tablet Compression Machines used in UPDPL
 In total 6 machines are in use.
 One GMP model, Rotatory tablet machine (double rotation) used of Candane, Ahmedabad.
 This model has 29 stations.
 Output - 300 - 400 per minute.
 Beside 3 single rotatory and 2 rotatory modles are in use.
 Besides 3 single



















Rotary press showing position of cycle




(Movement Of Tablets On DOUBLE ROTARY PRESS)




 The Granulation Section has big machines like FLUID BED DRYER, PLANATORY ROTATORY MIXER, SHIFTER, MULTI MILL, and DOUBLE CONE BLENDER.
Information of machine that are related with granules production
I. FLUIDISED BED DRYER (BIG): - Mfd. By Alliance engineering company Bombay
• It is used for uniform and efficient drying of the products
• Fully automatic
• Lifting & tilting device of product container for easy handling.
• Capacity available for 5 kg to 500kg
• Option – steam heated or electric heated blower DOUBLE CONE BLENDER:- Mfd. By Gansons Limited Bombay Capacity – 1500lit.
• Efficient and versatile mixer.
• Ideal for mixing powders and homogeneous lubrication of
• granules
• Moc s.s. 304/316/316 l S.s baffles are provided
• Safety guard provided with limit switch interlocked to motor.
• Capacity 20lit. to 2500lit.
• Automatic loading and unloading facilities available

II. PLANATORY MIXTURE: - Mfd. By Gansons Limited Bombay
• Big, Capacity – 400 lit.
• Small, capacity - 200 lit.











III. MULTI MILL: - Mfd. By Gansons limited Bombay -55
R.P.M. -750 – 3000H. P.–3,
400Volt Sieve Size – 2\5\8mm
• Suitable foe dry granulation/ pulverization/ shredding & chopping of material.
• ulti speed drive for various product grading
• Easy dismantling and cleaning.
• utput 100 to 250 kgs/hr depends upon product & the screen size.
• Moc s. s. 304/316/316 l
• otor – 3hp/1440rpm, rotor dia. 250mm approx
• Beater – 12 nos with knife/ impact edge and 2 scrapper blades.
• Rotor speed – 720/1500/2100/3000 rpm apporx
• Overall dia – 900 l * 800 w* 1700h (in mm)
• CGMP model with documentation (iq, dq, pq, oq) – as option
IV. Mechanical shifter
• Sieve Size – 10






Tablet coating is the application of a coating material to the exterior of a tablet with the intention of conferring benefits and properties to the dosage form over the uncoated variety.

 Types of tablet coating
Three main types are in use:
• Film coating
• Sugar coating
• Press coating

Film coating is the major technique:
All new coated products introduced on to the market are film coated. Sugar coating is the more traditional technology and has seen no real development in recent years. The total output of coated tablet on a global basis, though it is still of some economic importance.

COATING OF TABLETS:
Tablet is usually based on one or more of the following objectives:-
(a) To mask the taste, odor or color of the drug.
(b) To provide physical and chemical protection for the drug.
(c) To control the release of drug from the drug.
(d) To protect the drug from the gastric environment of the stomach with and acid resistant enteric coating.
(e) To improves the pharmaceutical elegance by use of special color and contrasting printing.
THERE ARE THREE PRIMARY COMPONENT INVOLEVE IN TABLET COATING:
1) Tablet properties
2) Coating process
• Coating equipment
• Para meters of coating process
• Facility and ancillary equipment
• Automation in coating process
3) Coating composition

COATING PROCESS:
The principle of tablet coating is relatively simple. Tablet coating is the application of coating composition to moving bed of tablet with the concurrent use of heated air to facilitate evaporation of the solvent. The distribution of coating tablet is accomplished by the movement of the tablet and either perpendicular or vertical to the application of the coating composition.
TYPE OF TABLET COATING:-
1. Sugar coating.
2. Film coating.
3. Enteric coating.

SUGAR COATING:-
The basic coating process involve following steps:
 Sealing
 Sub coating
 Syruping (smoothing)
 Finishing
 Polishing

 Seal coating: - To prevent moisture penetration into tablet core, a seal coat is applied. This is specially needed in pan - ladling process, in which localized over wetting of a portion of the tablet bed occurs. Without seal coat, the over wetted tablet would absorb excess moisture leading to tablet softening or disintegration and effecting physical and chemical stability of final product.

 Sub coating: - The sub coating is applied to round the edges and build up the tablet size. The step consists of applying a sticky binder solution to the tablet followed by a dusting of sub coating powders and then drying.


 Syrup (smoothing/color) coating: - The purpose of step is to cover and fill in the imperfections in the tablet surface caused by sub coating and to impart the desired color to the tablet.

 Polishing: - The desired lusture is obtained in final step of the sugar coating process. The tablets can be polished in the clean standard coating pans or canvas–line polishing pan, by carefully applying powdered wax (bee wax, carnauba wax) or warm solution of these waxes in the naphtha or other suitable volatile oil
E.g.- Ciprofloxacin tablet I.P. 200 mg under the process of simple coating materials talc (75gm), alcohol 4.5 liter titanium, methylene chloride 10.5 liter, HPMC U.S.P. 60 kg of tablets.
o Blower of machine was used for drying the moisture content on the coated tablets.
o Pressurized steam was used to spread dye on tablet for coating.
FORMULATION USED IN SUGAR COATING
SEAL COATING SUB COATING POLISHING
Cellulose acetate phthalate Gelatin Wax, carnauba
Zein Acacia Bee wax, white
Wax sugarcane Wax paraffin
Oleic acid

Steps involved in sugar coating
Step 1:- Slack (1.5%) + alcohol (98.5%) solution 150 – 200 ml for 30 kg lot of tablets Step is doing to check moisture and make tablet hard. Hand pricking method used in it powder is sprayed in the coating pan.
Step 2:- Sub coating: sypup: 20literD.M.water + 40 kg sugar + sodium benzoate is used. Gum syrup: Acacia + gelatin + Calcium Carbonate + talc (5%) + starch (2%) + Titanium dioxide
Step 3:- Talc paste 500gm + syrup + gum syrup 200ml
For finishing of tablet 3-4 coats
Step 4:- Gelatin syrups for shining and D.M. 400 – 500 ml 2-3 coat
Step 5:- Plane syrup 1-1.5 lit. to make smooth color
Step 6: - Color + syrup for tablet polishing bee wax (1%) 500ml, Carnauba wax (1.5%); talc in carbon Tetrachloride/chloroform/benzene was used.
For hexa vitamin cossfera color is used. When a tablet becomes gummy and threads are formed on the hand with touch in Calcium carbonate powders are spread.
FILM COATING:-
Is a thin coating of water soluble material which protects the drug substances from the atmospheric condition?
Two methods are used:
a. Pan pored method
b. Pan spray method
EQUPEMENTS:-
1) Standard coating pan
2) Perforated coating pan or partially perforated drum (Acceela cota and High coater system and Driacoater)
3) Fluidized bed (air suspension) coater.



Capsules are solid doses form usually containing one dose of drug enclosed within a small, water-soluble shell of suitable form of gelatin. Solid substances are enclosed in hard capsules where as soft capsules are suitable for enclosing liquids and semisolids.

Hard Gelatin Capsules
These are referred as dry-filled capsules. They consist of two sections namely the body & caps. Hard gelatin capsules are made from a mixture of gelatin, sugar, water; with/ without suitable colouring agents. Glycerin and sorbitol are commonly used as plasticizers, their exact proportion depending upon the use of capsules and their likely storage conditioned the preservatives are included; generally 0.2% of the mixture of methyl paraben and propyl paraben (4:1) is used.

Process of Hard Gelatin Capsules
Diluents:- Lactose, Mannitol, Sorbitol, starch etc.
Protective /Sorbents:- Oxides, Carbonates of magnesium and Calcium
Glidant: - Talc
Antidusting agents: - Inert edible oils

Filling Equipments
At present, at least nine manufacturers of capsules filling equipment are either located in or selling their products within the United States. Most of the units manufactures outside the United State have local representatives. They are: -
Eli Lilly and Company, Indianapolis, IN
Farmatic SNC, bologna, Italy
Hofliger and karg Waiblingen, Germany
Macofar SAS, Balogna, Italy
mG2 S.p.A., Bologna, Italy
Osaka, Osaka, Japan
Parke-Davis and Company, Detroit, MI
Perry Industries, green Bay, WI
Zanasi Nigris, S.p.A., Bologna, Italy













The Lilly machine describes as

 The empty capsules are fed from the storage hopper though the rectifying unit.
 Into the two piece filling ring Cap Section &Body Section.
Rectification is based on dimensional differences between the outer diameters of the cap and body portion of capsule. As the ring Cap Section &Body Section is rotated, a vacuum is applied on its underside.
 This vacuum seats the bodies into the lower half of the ring, while the cap is retained in the upper portion.
 The two piece of the ring are separated, and the cap containing portion is placed aside.
 The body- containing portion of the ring is placed on a variable speed turntable and is mechanically rotated under the powder hopper
 It contains an auger for the forced delivery of the powder. After one complete rotations of the ring, the powder hopper is removed, and the two segments of the ring Cap Section &Body Section are rejoined.
 The intact ring is positioned in front of the Peg Ring, and the closing plate is pivoted to a position approximately 180 degrees.
 Pneumatic pressure is applied to the Peg ring which forces the capsules body into the cap, and the closing plate holds the caps in position.
 Ejection of the filled capsules from the rings cannot occur with the plate in the closing position. For ejection of the capsules, the pressure is released the closing plate is restored to its original position, and capsules are expelled through the upper portion of the ring.
 Normal closing and ejection occurs with the peg ring in a vertical position with a filled capsules being collected through a chute in a collection chamber.


Precaution of capsules filling

• The body containing ring must be flat across its surface to avoid creating volumetric differences from one area of the ring to another.
• The powder hopper must be properly positioned during the filling operation to avoid uneven powder distribution from the auger. The proper location includes consideration of both the centering of the auger over the ring holes and the parallelism between the lower surface of the hopper and the upper surface of the ring.
• Extreme variation in powder level in the filling hopper can cause uneven powder flow, resulting in excessive fill weight variation.
• The individual rods in the peg ring must fit the rings being used, be of uniform length, and be perpendicular to the closed plate.
• Flow property of the powder being filled must be such that a constant amount of powder is available for delivery from the auger. Diluents and Glidant should be selected with this phase of the operation in mind.



Approximate capacity of CAPSULES vs. NUMBER

S.No. Number Capacity
1 000 950
2 00 650
3 0 450
4 1 300
5 2 250
6 3 200
7
8
4
5 150
100





Teeth13 Teeth14
A B C A B C
X 3.4 2.7 4.3 3.7 2.9 4.6
y 13.6 10.8 17 14.66 11.6 18.3
z 6.8 5.4 8.5 7.3 5.8 9.1
• 480 capsules is formed in 250mg.
• 420capsules is formed in 500mg.
• The name of 100 mg drug is Doxycycillin which is packed in 250mg capsule



1) SEMI AUTOMATIC CAPSULE FILLING MACHINE:-

 The empty capsules are feed into the storage hopper through the rectifying unit into the two piece filling ring (3A & 3B). Rectification is based on the dimensional differences between the outside diameter of the cap and body portion of the capsule. As the ring rotated, a vacuum is applied on its underside. This vacuum seats the bodies into the lower half of the ring, while the cap are retained in the upper portion. The two pieces of ring are separated and the cap containing portions are kept aside.
 The body containing portion of ring is placed on a variable speed turntable and is mechanically rotated under the powder hopper which contain an aurger for the forced delivery of the powder. After one or more complete rotation of the ring, the powder hopper is removed, and two portion of ring are rejoined.
 The intact ring is positioned in front of the peg ring and the closing plate is pivoted to a position approx 180 degrees.
 PNEUMATIC PRESSURE is applied to the peg ring which forged the capsule body into the cap, and the closing plate holds the cap in the position.
 For the ejection of capsule the pressure is released, the closing plate is restored it its original position.
 The capsules are expelled through the upper portion of the ring.
 The filled capsule bring collected through a cute into the collection chamber


2) AUOTOMATIC MACHINE
 The capsules are fed from the storage hopper through individual tubes and rectified into individual two piece side holders on continuous chain.
 The capsule are separated within the two pieces holders by applying vacuum to the lower portion, which pulls the body into it while the cap is retained in the upper holder.
 As the chain retaining blocks progress through the cycle, the cap containing upper holder is moved aside to a recess at the outer end of the conveying holder, exposing the lower holder containing the body.
 The powder is continuously mixed within the powder hopper and is maintained at a constant level prior to discharge.
 The carrying units now are carried under a series of 12 volumetric dosing nozzles each of which picks up the product from a rotating container, first compressing and then ejecting the powder into the capsule bodies.
 The cap container is positioned over the body blocks and closing is accomplished by both upper and lower pins. Ejection is accomplished by compressed air. Each station is equipped with safety device that automatically stop the machine in the event of irregularity. Capsule carrying holder is by air prior to being returned to the rectified station.

WEIGHT INSPECTION RECORD
 Product batch no. batch size
 Machine no. , capsules size operated by.
 Avg. weight M\C started at M\C stopped at
 D.T. variation Wt. of Empty cap.
 Time avg. weight of cap.
 Total no. of capsule No. of containers
 Remarked supervisor date
OBSREVATION OF CAPSULE FILLING SECTION
 The section has a cleaned & humidity controlled room which was centrally air conditioned.
 The capsule comes under various sizes such as 000, 00, 01, 2, 3, 4, & 5.
 Majority of capsule were 0 & 2 no.
 The capsules are properly packed into the strips. E.g.
1) CEPHALEXIN CAPSULE I.P. 250 MG OF AVG. WEIGHT 330mg/ 5mg, THEBATCH SIZE IS 40 LACKS, Batch No. is CF – 1, Size – 2 under process of filling on machine no. SA – 9 with the speed of 33500 – 3360 capsule per hours.


2) AMOXYCILLIN CAPSULE I.P. 500mg, Batch no. AMC5 I , Size no. 0, avg weight 590 mg/ 5mg under process of filling and sealing on machine no. SA – 8.

DIFFICULTIES OF CAPSULE:-
 Deliquescent or hygroscopic powder
 Eutectic mixtures
 Addition of inner powder
 Filling of granular powder
 Use of two capsule
 Liquids

EVALUATION OF CAPSULE
 Uniformity of weight
 Content of active ingredient in capsule
 Disintegration
 Dissolution

PRECAUTIONS INVOLVED IN THE STORAGE OF CAPSULES

 Protection from moisture.
 Store between 15 to 25 degree Celsius with 45 to 55% relative humidity.
 Keep away from any direct source of heat and sunlight.
 Keep bags sealed when not in used.

POLISHING AND SORTING OF CAPSULES
Finished capsules from all filling equipments require some sort of dusting and/or polishing operation before the remaining operations of inspection, bottling, and labeling are completed. Dusting and polishing operations vary according to the type of filling equipment used, the type of powder used for filling, and the individual desire for the finished appearance of the complete capsules.
• Pan polishing: - The Accelacota tablet coating pan may be used to dust and polish capsules. A polyurethane or cheese cloth liner is placed in the pan, and the liner is used to trap the removed dust as well as to impart the gloss to the capsules.
• Cloth dusting: - The bulk filled capsules are rubbed with the cloth that may or may not be impregnated with inert oil. This operation is hand operation, but one that can handle reasonable volumes, and that results in a positive method for removal of resistant materials. In addition, it imparts a somewhat improved gloss to the capsules.
• Brushing: - Capsules are fed under rotating soft brushes, which serves to remove the dust from the capsule shell. This operation must be accompanied by a vacuuming for dust removal. Some materials are extremely difficult to remove by brushing, even to the point of impregnating the brushes and causing scratches or deformation of the capsules.
ROTOSORT: - It is a new filled capsule sorting machine sold by ELI LILLY & company. It is a mechanical sorting device that removes loose powder, unfilled joined capsules, filled or unfilled bodies and loose caps. It can handle up to 150000 capsules per hour, and it can run directly off a filling machine or be used separately.
Seidenader Equipment: - It offers two units that may be used separately or may be combined in the finishing of filled gelatin capsules. A belt is available that presents capsules for visual inspection, and it may include a vacuum system to automatically removed unfilled capsules. Cleaning and polishing machine PM60 may be used to polished capsules. It consists of two lamb’s wool belts moving in opposite directions. The capsules are carried on the lower belt, and both belts are under suction.


Blister packaging is a push through packs (PTP). It is used for many unit dosage forms.

THIS PACKAGING HAS BEEN USED EXTENSIVLY FOR MANY GOOD REASONS:

1) It provides physical protection against shock, vibration & compression etc.
2) It provides barrier protection against water, water vapors, dust, oxygen etc.
3) It provides excellent environmental protection.
4) It is coupled with esthetically pleasing and efficacious appearance.
5) It provides users for convenience child resistant and now temper resistant also.
6) It include anti theft device.
7) There is no chances of agglomeration e. g small object is typically grouped in on pack.

MACHINERY
THERE ARE TWO TYPES OF BLISTER PACKING MACHINE:
1) Automatic blister packaging machine
2) Semiautomatic machine
BLISTER PACKAGING MACHINE is high speed packaging machine designed for packing of product from both side. These machines are very cost effective as they need less electricity as well as durable in nature.





DPB-250E Flat-plate Automatic Blister Packing Machine














PROCESS OF FORMING BLISTER PACKS:-
The blister packs is formed from heat softening a sheet of thermoplastic resin (PVC FILM) and vacuum drawing the soften sheet of plastic into countered mold. After cooling the sheet have been removed from the molds and sent to filling station of packing machine. A semi rigid blister is filled with product and lidding with heat sealable backing materials (printed aluminium foils) .After that it has been cut down by cutters
There are two types of cutters/ blade:
1) Single phase cutter
2) Double phase cutter

In first one there is only one cutter i.e. only one pack can be cut down at a time (10 tablet packs).
In second one there are two cutters i.e. two packs
can be cut down at a time (10, 10 packs).

TYPE OF BLISTER BACKING MATERIAL
Backing material or lidding is either PUSH
THROUGH & PEAL THROUGH or PEALABLE TYPE
FOR push trough the backing material is heat sealable
aluminium foil.
FOR pealable backing material have be used to meet
requirement of child resistant packaging. This type of
packing have a degree of puncture resistant so the child A Blister Pack
could not remove the liding by push as well as it has a
degree of tensile strength to allow the liding to be pulling away from blister.
MATERIAL USED IN BLISTER PACKING
1) PVC(POLY VINYL CHLORIDE)
2) POLY VINYL DICHLORIDE (aclar)
3) POLYPROPYLENE
4) CYCLO OLEFIN COPOLYMER
5) POLYAMYL
6) CELLULOSE ACETATE BUTYRATE(CAB)

1. PVC: They are the cost effective, compactable and can be mould in any shape with minimal shrinkage property. They are of various grades.
2. POLYPROPYLENE:-They are difficult to shape but due to their unstable shrinkage factor and soft nature, they are still used. The main advantage of this system is
having lower moisture absorption coefficient, transparency and glossy appearance.

QUALTY CONTROL TEST FOR BLISTER PACKING
1) BLISTER PACKS LEAK TESTER
2) AUTOMATIC IN LINE TESTER
3) EXTRACTIBLE & LEACHABLE CONTENT TEST
4) MECHANICAL FORCE TESTING
5) VISUAL INSPECTION
6) OFF LINE BLISTER INSPECTION

 BLISTER PACKS LEAK TESTER:- Conventionally blister packs tablet has been tested with methylene blue dye but it was cumbersome and time taking procedure therefore the leak tester has been replace with same. They are validated due to the introduction of sensor inside these leak testers. Swelling of each blister is tested.

 AUTOMATIC IN LINE TESTER: - They are the modified form of the previous one. The compact machine is integrated for 100 percent in line leak detection for automatic sample testing between the body cavity and the lidding foil.

 EXTRACTIBLE & LEACHABLE CONTENT TEST: - Certain instrument such as mass spectrophotometer, gas chromatography is done or used for the estimation of extractible specimen of blister packs.

 VISUAL INSPECTION: - Visual inspection like pin holes, color, shape, shrinkage, print, gloss, quality of printing.

 OFF LINE BLISTER INSPECTION: - An automatic inspection machine is attributed with the load of blister for the inspection of integrity content as per GMP requirement. They are used for the detection of missing tablet, wrong shape of tablet, tablet position, crack tablet, scratched tablet without any embossing, pin hole, incomplete cutting of blister, print defects, less developed cavity, torn pocket etc.


THE ADVANTAGE OF BLISTER PACKAGING OVER
OTHER PACKGING

1) It provides packaging integrity of each product or individual dose.
2) The compliance pack and calendar packs are also possible in blister packaging. and provide visual information to the people.
3) The assurance for other product.

USES
1) Blister packs are used for packaging of tablets, capsule lozenges etc.
2) Blister packaging is used for packaging OTC drug


FIG:- STRIP PACKAGING MACHINE
“A strip packaging is a form of unit dose packaging that is commonly used for the packaging of tablets and capsules. “

A) Strip Packing Machine
1) Primary Packing
M/S Gansons Machine Bombay
Environment Control Specifications
RH-NMT-50%
Temperature NMT 30degrees celcius
Machine Temperature 185degrees celcius
Speed 144strips / minute

2) Secondary Packing
In small cartons
3) Tertiary Packing
In big cartons
Packing defects under stripping
1) Text and color
2) Coding
3) Punctures
4) Empty Pockets
5) Cracking
6) Chipping
7) Denting
8) Stamming on surface
9) Leakage

PROCEDURE Strip Pack

 A strip package is formed by feeding two webs of a heat-sealable flexible film through either a heated crimping roller or a heated reciprocating platen.
 The product is dropped into the pocket formed prior to forming the final set of seals. A continuous strip of packets is formed, generally several packets wide depending on the packaging machine’s limitations.
 The strip of packets is cut to the desired number of packets in length. The strip formed are usually collated and packaged into a folding carton.








Strip Packaging The product sealed between the two sheets of film usually has a seal around each tablet, with perforations usually separating adjacent packets.

MACHINERY
TYPES OF STRIP PACKING MACHINES:-
 Vertical Strip Packaging Machines.
 Horizontal Strip Packaging Machines.
VERTICAL STRIP PACKAGING MACHINES:-
These includes:
 VERTICAL STRIP PACKAGING MACHINE.
 COMPACT VERTICAL STRIP PACKAGER.





















“ORS POWDER MIXED AND GRANULATED IN GRANULATION SECTION BY DOUBLE CONE BLENDER MACHINE ONLY PACKING WAS DONE IN THIS SECTION”


 Formula for Oral Rehydration Salt Citrate I.P. 270 g

NaCl IP 3.5g

KCl IP 1.5g

Sodium Citrate 2.9g

Glucose anhydrous 20g

To be dissolved in 1 liter of water


 Procedure
• Milling by multimill and sifting.
• Blending by double cone blender.
• Sifting of blend.
• Goes to Q.C. and packaging section.


 Precautions
• Keep away from moisture.


 Dose
• Age below 2 years 50 to 100 ml (1/4th glass)
• 2-10 years 100- 200 ml (1/2 glass)
• Above 10 years as much as able to drink


 Equipment
Semi automatic ORS sachet filling and sealing machine manufactured by M/S Gansons Bombay; Capacity – 60 sachet in1 minute. Packing done by foil packing.







The department has following chambers:-
• Working laboratory.
• Instrument room.
• Testing laboratory.
• Record room.
• Separate working area for alcoholic/inflammatory processes.
• Sterilizing apparatus room.
• Microbiology laboratory.
• Reproductive laboratory.
• Dispensary.
• Work manager & deputy manager chambers etc.
QUALITY:-
The word “Quality” with reference to a dosage form is comprehensive and refers to characteristics like the potency, uniformity, purity, pharmacological action, stability etc.
Although the responsibility for assuring product quality belongs principally to quality assurance personnel, it involves many departments and disciplines within a company.
QUALITY CONTROL (QC):-
The Quality control process involves:

1) Quarantining of a batch

2) Sampling of drugs from the batch

3) Testing with respect to set parameters

4) Acceptance and Rejection of the batch

5) Destruction of rejected batch

6) Samples of the accepted batches are stored for a period of 3 years

The concept of product quality depends on more than just proper sampling and adequate testing of various components and the finished dosage form.
The Q.C. department of UPDPL is responsible for regulating the quality of product through where industry measures actual quality performance, compares it with standard of national customer company requirement before releasing it to the market for better customer acceptance. UPDPL has a full-fledged quality control department with qualified staff in addition to a commercial testing license.
For drugs supplied to the GOUP an additional level of testing is done at the Analytical Testing Corporation (ATC) at Lucknow. The microbiological testing section is separate from the chemical testing section
Quality Control TESTS:-
In UPDPL following quality control testing is generally employed for assessing the quality of different dosage forms:
 For Tablets
a) Weight Uniformity
b) Hardness
c) Thickness
d) Friability
e) Dissolution Test
f) Disintegration Test
 For Capsules
g) Weight variation
h) Disintegration and dissolution Time
i) Drug content Uniformity
j) Diameter and thickness (outer and inner of cap and shell)
 For Powders (ORS)
k) Particle size
l) Limit test for heavy metals like Arsenic, Lead, Iron, Sulphate etc.
 For Disinfectant and Antiseptics
RWC (Reidel Walker Coefficient) test
Quantitative and Qualitative Analytical Methods are being followed in estimation of authentic nature of pure products and actual and actual quantity of pure, drug content in different dosage form simultaneously.
Quantitative analysis is basically done by Titrimetric method, semi or fully automatic machines for obtaining most accurate results with high precision.
INSTRUMENTS / MACHINES THAT ARE COMMONLY USED PRESENTLY IN UPDPL
1) pH meter Mode L1-10T Euco Pvt. Ltd. Hyderabad, India
2) Remi: ATO mix blender
3) Electronic photo-fluorometer Coleman instruments incmaywood ILL
4) Spectronic 20 Bausch and Lomb
5) HPLC connected with Monitor and Printer
6) Elnova ELCVT constant voltage transformer
7) UV visible spectro-photometer Shimadzu with printer
8) Automatic Potentiometer Titrator AT-38B Spectra lab
9) Colorimeter
10) Polari meter
11) MettlerH5-1A electronic balance
12) Six stage dissolution rate test apparatus IP/BP/USP
13) Friability test apparatus
14) Electronic Balance (Atco)
15) Disintegration Test Apparatus

 WEIGHT VARIATION:- Weigh individually twenty units taken at random or, for single-dose preparations presented in individual containers, contents of twenty units, and determine the average weight (mass). Not more than two of the individual weights (masses) deviate from the average weight (mass) by more than the percentage deviation and none deviates by more than twice that percentage.
Average weight of tablet % deviation
80mg or less 10
X >80mg or <250mg 7.5 X >= 250mg 5
 HARDNESS TEST:-
This test is intended to determine, under defined conditions, the resistance to crushing of tablets, measured by the force needed to disrupt them by crushing.
Apparatus
The apparatus consists of two jaws facing each other, one of which moves towards the other. The flat surfaces of the jaws are perpendicular to the direction of movement. The crushing surfaces of the jaws are flat and larger than the zone of contact with the tablet. The apparatus is calibrated using a system with a precision of 1 Newton.






Fig: Monsanto Hardness Tester
Method
Place the tablet between the jaws, taking into account, where applicable, the shape, the break-mark and the inscription; for each measurement orient the tablet in the same way with respect to the direction of application of the force. Carry out the measurement on 10 tablets, taking care that all fragments of the tablets have been removed before each determination.
This procedure does not apply when fully automated equipment is used.
Expression of the results
Express the results as the mean, minimum and maximum values of the forces measured, all expressed in Newton’s.
 FRIABILITY TEST:- This test is intended to determine, under defined conditions, the friability of uncoated tablets, the phenomenon whereby tablet surfaces are damaged and/or show evidence of lamination or breakage when subjected to mechanical shock or attrition.
Apparatus
Use a drum with an internal diameter between 283 and 291 mm and a depth between 36 mm and 40 mm, made of a transparent synthetic polymer with polished internal surfaces and not subject to static build-up (see Fig.). One side of the drum is removable. The tablets are tumbled at each turn of the drum by a curved projection with an inside radius between 75.5 mm and85.5 mm that extends from the middle of the drum to the outer wall. The drum is attached to the horizontal axis of a device that rotates at 25 ± 1 r/m. Thus, at each turn the tablets roll or slide and fall onto the drum wall or onto each other.




Method
For tablets weighing up to 0.65 g each, take a sample of twenty tablets; for tablets weighing more than 0.65 g each, take ten tablets. Place the tablets on a sieve no. 1000 and remove any loose dust with the aid of air pressure or a soft brush. Accurately weigh the tablet sample and place the tablets in the drum. Rotate the drum 100 times and remove the tablets. Remove any loose dust from the tablets as before. If no tablets are cracked, split or broken, weigh the tablets to the nearest milligram.
Generally the test is run once. If the results are doubtful or if the mass loss is greater than 1%, repeat the test twice and determine the mean of the three tests. A maximum loss of 1% of the mass of the tablets tested is considered to be acceptable for most products.
For tablets having a diameter of 13 mm or greater, problems of reproducibility may be encountered due to frequent irregular tumbling. In such cases, adjust the drum so that the tablets may fall freely and do not bind together when lying next to each other, adjusting the drum so that the axis forms a 10° angle with the base is usually satisfactory.
Expression of the results: The friability is expressed as the loss of mass and it is calculated as a percentage of the initial mass.


















Friability Test Apparatus

Operating procedure:
1. Ensure that instrument is clean &free from dust.
2. Accurately Weigh 10 Tablets.
3. Open the apparatus from one removable side of drum.
4. Transfer the tablets in it& close the drum tightly.
5. Switch ON the instrument.
6. Place the timer switch to min. position.
7. Wait till rotation stop.
8. Open the drum & remove any loose dust or broken small pieces of tablets.
9. Weigh the remaining tablets.
10. Switch OFF the instrument when not in use.

Wt. of tablets (before rotation-after rotation) x 100
% Friability = Wt. of tablets before rotation

Calibrator: - Start the rotation of drum as per operating Procedure
a) Count the no. of rotation for exactly 4 min.
b) Repeat the counting for 2 to 3 times.
c) Determine the avg. RPM.
d) Avg. RPM should 24-26 Revolution/minute.
e) Calibration frequency –Half Yearly.


 DISSOLUTION TEST APPARATUS:-
Digital six stage Dissolution Test Apparatus (I.P, B.P and U.S.P)

Standard operating procedure:

1. Ensure that instrument is clean &free from dust. Ensure the instrument is connected to stabilize power supply.
2. Check water level of bath from mark given at the side of bath of apparatus and fill up to mark if necessary.
3. Deacerate the dissolution medium.
4. Check pH of the medium at 37 +/- 0.5 adjust the pH +/- 0.05 unit of pH specified in monograph. Incase of buffered solution.
5. Filled the stated volume of dissolution medium in cleaned bowl of apparatus.
6. Switch ON the power. Instrument will initialize itself The display will show temp. / Time & RPM.
7. For setting RPM press RPM key from the front panel. Settling screen fort the RPM will be displayed RPM can be set from 50-150.
8. After setting the desire speed for the stirrer status “START” or “STOP” by using “START” or “STOP” key respectively.
9. Temperature is automatically controlled at 37˚C by inbuilt thermostat sensor.
10. Current temperature will display on panel.
11. For sample interval setting press the TIME key from the panel. This will display the screen for setting the sample time can be set from 00 minute to 99 hr 59 minutes.



 DISINTEGRATION TEST:-

The disintegration test determines whether tablets or capsules disintegrate within a prescribed time when placed in a liquid medium under the prescribed experimental conditions.
Disintegration is considered to be achieved when no residue, except fragments of undissolved tablet coating or of capsule shell, remains on the screen of the test apparatus or adheres to the lower surface of the disc if a disc has been used; if any other residue remains, it consists of a soft mass having no palpably firm, unmoistened core.

Apparatus : A rigid basket-rack assembly supporting six cylindrical glass tubes 75.0 to 80.0 mm long, 21.5 mm in internal diameter and with a wall thickness of about 2 mm.

Disintegration Test Apparatus
i. Procedure starts up
 Ensure that instruments are free from dust.
 Connect the three pin plug to main 230 volt single phase A.C.
 Put the glass beaker (1000 ml capacity.) on the hot plate on the top of units.
 Put the thermometer (range 0to50˚c) at the placement for in basket rack assembly.
 Fill the beaker with warm water /medium at 37˚c +/-2˚c so that the volume of water /medium in such the wire mesh at its height point is t least 25mm below the surface of liquid 2 at its lower point is at least 25mm above the bottom of the beaker.
 Maintain temperature of water /medium at 37˚c +/-2˚c with help of thermostatic device.
ii. Operational procedure
 Switch ‘ON’ the main switch on front panel.
 Check the calibration status of instruments.
 Put one tablets/capsules in each of six-glass tube add the dish to each tube.
 Switch on the motor switch to operate the apparatus for specified time and immediately start the stopwatch.
 When all the tablets / capsules pass out from the mash top the stopwatch and stop the disintegration apparatus.
 The time will be shown on stopwatch.
 Record the time at which all six tablets get disintegrated.
 Inform the Q.C head, if tablets are not getting disintegrated. Within specified /set time.
 In case of failure repeat the test with addition of 12 units. All the tablets should comply with required.
 Clean the basket & beaker.
iii. General case and Precaution
 The sequence shaft should be lubricated with mobile oil once in a week.
 The equation should never be switch ‘ON’ unless beaker filled with water or kept on hot plate
 Do not holds square bar while, it is moving otherwise the gear will be damaged.

SPECTROPHOTOMETER

1. Open the display unit and turn on the main switch.
2. Initialization takes place about 2 min and instrument comes in “mode condition” or “ Previous Mode”.
PHOTOMETRIC MODE : -
1. Press I number key of “Mode” for photometric mode and it will show wavelength and absorbance.
2. Press “go to wavelength key, enter required wavelength and press enter key.
3. Fill both the cuvett (UV/ Visible as per requirement) with the blank and put in their place.
4. Close the lid and press “AOTO ZERO” key to match the cuvett.
5. Fill R.S. or sample solution in the cuvett.
6. Close the lid absorbance display on screen.
7. On pressing ‘F3’ key measurement screen will appear in table form.
8. Fill the K value by pressing “F4” key and press in table form.
9. On pressing “START” key, % of content will appear on screen.
Press “PRINT” and get the printed report

POLARIMETER

Ensure that the instrument and all its part are clean and free from dust.
1. Switch on the instrument and let sodium lamp illute to its maximum brightness.
2. Set the alignment of the sodium lamp compartment to the optical bench.
3. Ensure that all the settings are done in the Zero- Zero positions.
4. Open the polarimeter tube compartment and place the polarimeter tube which is filled with sample in such a way as to avoid air bubbles.
5. Specific attention should be paid to temperature control of the solution and of the polarimeter.
6. Note the observation reading and also perform a blank determination in the similar manner.
7. Observation are done by observing through telescope when the half dark and half light portion of the circle has in equilibrium.
8. This half dark and half light portion is matched with a knob by rotating it clockwise/ anticlockwise direction. It is also defined as dextro +) or laevo (-) rotatory respectively.
10.Clean the instrument and keep under cover when not in use.
PRECAUTION:-
1. Proper handling of the instrument.
2. Temperature should be maintained.

H.P.L.C. OPERATING PROCEDURE
1. Turn ‘ON’- (1st) Binary pump switch (2nd) detector switch.
2. See detector screen for successful calibration (do accordingly).
3. Turn ‘ON’ C.P.U. and monitor switches.
4. Select ‘Breeze’ system. wait till booting is over. Check all configurations are on the monitor screen.
5. Select operator name from manage Breeze, change prefilter, guard tube and column (if necessary)

6. Remove the air from the pump through syringe and run acetonitrile/ Methanol at 0.2 ml/ minute flow rate for preconditioning the column. (2 hours)
7. Filter fresh distilled water by membrane filter and degassed. Prepare mobile phase, filter and degassed. Prepare Diluting solvent, filter and degassed.
8. Weigh R.S. and sample accurately and prepare as per monograph.
9. Run mobile phase at flow rate 1.0 ml/ minute (or as per method) till constant pressure is achieved.
10. Select method and equililibrate Mobile Phase till straight line/ curve is achieved. Check wavelength on detector screen.
11. Abort and click injection. Filter R.S name run etc and click O.K. Inject R.S. through injector. Give 3 to 5 replicate injections. Check R.S.D. though wizard.
12. Inject sample all batches one by one as R.S.
13. Calculate drug % by comparing R.S. peak area with sample peak area. Take out print.
14. After work is over do washing of membrane filter vessel, syringe, needle, etc. by H.P.L.C. water. And by hot water thoroughly.









The Marketing setup of the company can be classified in two division i.e. Institutional Sales and Open Trade Marketing.

Institutional Sales.
UPDPL is basically established to cater the need of U.P. Govt. Health Deptt. The U.P. Govt. Health Deptt. has also reserved 39 items in favour of UPDPL which are exclusively to be purchased from UPDPL. The U.P. Govt. Health Deptt. is purchasing the medicines upto the extent of Rs. 25.00 crores per annum as centralized orders. UPDPL is successfully executing the orders to Addl. Director, levels with their entire satisfaction in respect of quality and quantity. On delivery of the goods at A.D. Mandals the Marketing team of Institutional Sale is being deputed for verification of the bills for onward payment from the office of Director (Stores), Medical & Health Services, Swasthya Bhawan , Lucknow.

Apart from the above UPDPL is also catering the entire need of all periphery officers i.e. CMO,CMS (Male/Felame), DTOs etc. UPDPL has developed a team for Institutional Sale of 9 – 10 persons who are deployed in the various distt. H.Qs. to collect the requirement and timely execution of the orders to the periphery officers.

In order to increase capacity utilization of the plant UPDPL have expand their marketing activities in other states also. UPDPL have have secured recognition in different states like Jharkhand, M.P., Andra Pradesh., Gujrat and Pondicherry etc. UPDPL is participating in the tender enquiries floated by the different Sate Govt. as well as Central Govt. Institutions/Govt. 5-6 products have been approved by the E.S.I.C, New Delhi on the basis of 1st lowest and IInd lowest. The Andhra Pradesh Govt. have also approved 2 produdcts on the basis of the lowest rates.

The executions of the orders of other state are being made by the company through Distributors/ C& F net work.


25 comments:

  1. Dolar’s quality assurance and design concept is comparable to the best in the Indian industry. Our businesses work together with one simple and seamless set of values for customers like bakery Equipments, machineries in India.

    ReplyDelete
  2. Dolar’s quality assurance and design concept is comparable to the best in the Indian industry. Our businesses work together with one simple and seamless set of values for customers like bakery Equipments, machineries in India.

    ReplyDelete
  3. Dolar’s quality assurance and design concept is comparable to the best in the Indian industry. Our businesses work together with one simple and seamless set of values for customers like bakery Equipments, machineries in India.

    ReplyDelete
  4. Dolar’s quality assurance and design concept is comparable to the best in the Indian industry. Our businesses work together with one simple and seamless set of values for customers like bakery Equipments, machineries in India.

    ReplyDelete
  5. Thanks for sharing with us
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