Non sterile manufacturing process technology

• PRESENTD BY :-
• PATIL PRANJAY SADASHIV.
• FIRST YEAR M.PHARM.
• DEPARTMENT OF QUALITY ASSURANCE.
H. R. Patel Institute of Pharmaceutical Education
and Research, Shirpur
IN PROCESS-QUALITY CONTROL
TESTS FOR TABLET AND CAPSULE

NON STERILE
MANUFACTURING
PROCESS
TECHNOLOGY
2

•Introduction
•Importance of IPQC
•Scope
•General IPQC tests
•IPQC tests for tablet
•Weight Variation
•Content uniformity
•Hardness
•Thickness
•Friability
•Dissolution & Disintegration
•Moisture content
•References
Contents
3

What is Manufacturing?
1. Manufacturing is the making of goods by hand or by machine that
upon completion the business sells to a customer.
2. Items used in manufacture may be raw materials or component
parts of a larger product.
4

Manufacturing flowchart of non sterile product
Dispensing
Shifting
granulation
Drying and sieving
Lubrication
Compression
In process checking
Packging
Final product analysis and release

What is IPQC :
1. IPQC is concerned with providing accurate, specific, and definite
description of procedures to be employed from the receipt of raw
materials to the release of finished dosage forms.
2. IPQC procedures are generally quick, simple and rapid tests or
inspection that carried out at on going manufacturing.
3. In process quality control, IPQC tests are performed within the
production area.
6

1.To detect the errors
2.To minimize the human errors.
3. Provides accurate, specific, and definite description of the
procedure to be employed.
4.To enforce the flow of manufacturing and packing
operations according to established routes and practice.
Why we need IPQC?
7

In process quality control are particularly important where
a process may be vary with time such as tablet weights,
fill volume, etc
Scope :
8

• Disintegration apparatus
• Dissolution apparatus
• Friability testing apparatus
• Bulk density apparatus
• Tablet hardness tester
• Infra- red moisture content measuring apparatus
• U.V Spectroscopy
Instrument used in IPQC department :
9

a) Identity tests:
These tests are qualitative chemical methods used to confirm the actual
presence of compound For example: colour formulation.
b) Quality tests:
These tests are the physical methods used to measure accurately the
characteristics properties of drug. For example: Absorbance
General IPQC tests:
10

c)Purity tests:
Purity tests are designed to estimate the levels of all known and significant
impurities and contaminants in the drug substance under evaluation.
For example clarity test for the solution.
d) Potency tests:
Potency tests are assays that estimate the quantity of active ingredient in
drug.
11

• Official Pharmacopeial Tests:
• Uniformity of weight
• Uniformity of Drug Content
• Disintegration test
• Dissolution test
• Non-Official (Non- Pharmacopeial )Tests:
• Hardness test
• Friability test
• Uniformity of Thickness
IPQC TESTS FOR TABLET :
12

1. The volumetric fill of the die cavity determines the weight of the
compressed tablet.
2. The weight of the tablet is the quantity of the granulation that contains
the labeled amount of the therapeutic ingredient.
3. After the tablet machine in operation the weights of the tablets are routing
checked to ensure that proper tablet weights are made.
Weight variation :
13

1. Randomly select 30 tablets. 10 of these assayed individually.
2. According to USP, content uniformity test is done for uncoated & film-
coated tablets containing less than 25% of the total weight and for all
sugar coated tablets.
3. The tablet pass the test if 9 of the 10 tablets must contain not less than
85% and not more than 115% of the labelled drug content and the 10th
tablet may not contain less than 75% and more than 125% of the labelled
content.
Content Uniformity Test:
14

It is the time required for the tablet to break into particles, the
disintegration test is a measure only of the time required under a
given set of conditions for a group of tablets to disintegrate into
particles.
Disintegration:
15

1. The USP disintegration apparatus consist of 6 glass tubes that are 3
inches long, open at the top, and held against a 10-mesh screen at the
bottom end of the basket rack assembly.
2. Frequency of tablet is 28-32 cycles/min.
3. This test is done on 6 tablets and the test is passed when all the 6 tablets
disintegrate.
Liquid used in disintegration:
Water, simulated gastric fluid (PH=1.2) or simulated intestinal fluid(PH=7.5)
Disintegration test:
17

1. Dissolution is performed to check the percentage release from the dosage
forms. i.e. Tablet.
2. Tablet breaks down into small particles which offers a greater surface area to
the dissolving media.
3. Disintegration test does not give assurance that particles will release drug in
solution at an appropriate rate, that’s why dissolution tests and its
specifications developed for all tablet products.
Dissolution test:
18

• IP apparatus
• Type 1 Paddle Apparatus
• Type 2 Basket Apparatus
• USP apparatus
• Apparatus1(rotating basket)
• Apparatus2(paddle assembly)
• Apparatus3(reciprocating cylinder)
• Apparatus4(flow-through cell)
• Apparatus5(paddle over disk)
• Apparatus6(cylinder)
• Apparatus7(reciprocating holder)
Dissolution test apparatus:
19

Apparatus‐1:
 A single tablet is placed in a small wire mesh basket attached to the
bottom of the shaft connected to a variable speed motor.
 The basket is immersed in a dissolution medium
contained in a 100 ml flask.
 The flask is cylindrical with a hemispherical bottom.
 The flask is maintained at 37±0.50C by a constant temperature bath.
20

Apparatus‐2
 It is same as apparatus‐1, except the basket is replaced by a paddle.
 The dosage form is allowed to sink to the bottom of the flask before
stirring.
 For dissolution test U.S.P. specifies the dissolution test medium and
volume, type of apparatus to be used, rpm of the shaft, time limit of
the test and assay procedure for.
 The test tolerance is expressed as a % of the labelled amount of drug
dissolved in the time limit.
21

Friabilator is the instrument which is used to detect the friability of the tablets .
Friability is the combined effects of shock and abrasions. So to resist shock and
abrasions friability test is done for the tablets.
 In this a no. of tablets are put in the friabilator and revolves at 25rpm,
dropping the tablets a distance of six inches with each revolutions.
Friability is a property that is related to the hardness of the tablet.
Friability test:
22

1. The amount of moisture present in the granule is called moisture content.
2. Generally the granules contain 2% moisture. It is required for the binding
of the powder or granules during compression in die cavity.
3. Percentages of moisture is calculated by using “moisture balance ”or
“IR Balance”.
4. The small amount of sample taken from oven to measure moisture content
& place in the moisture balance.
Moisture content:
23

1. The test measures crushing strength property defined as the
compressional force applied diametrically to a tablet which just
fractures it.
2. Among a large number of measuring devices, the most favored
ones are Monsanto tester, Pfizer tester, and Strong Cobb
hardness tester.
3. All are manually used. So, strain rate depends on the operator.
4. using the hardness tester, measure the hardness for 10 tablets.
Tablet Hardness :
24

1.Monsanto tester
2.Strong-cobb tester
3.Pfizer tester
Types of hardness tester:
25

1. The thickness of a tablet depends on the upper and lower
punches at the moment of compression.
2. Tablet thickness is an important QC test for tablet packaging.
3. Very thick tablet affects packaging either in blister or plastic
container.
4. The thickness of the tablet may be measured manually or by
automatic equipment.
Tablet Thickness:
26

Content of Active Ingredients
Weight variation
Content uniformity
Disintegration test
Dissolution test
Moisture permeation test
IPQC TEST FOR CAPSULE:
28

This test a sample of the contents is assayed as described in individual
monographs and calculates the amount of active ingredient in each
capsule.
According to IP the range for the content of active ingredient stated in
the monograph is based on the requirement that 20 capsules, or such other
number may be indicated in the monograph are used in the assay.
Content of Active Ingredients:
29

Weigh the emptied shell individually
Remove the contents of each capsule with the aid of a small brush
Weigh the 20 capsules individually
If not all of the capsule fall within the limits,
The individual weights should be within the limits of 90٪ and
110٪ of the average weight.
Weigh 20 capsule individually and determine the average weight.
Weight variation : 1)For hard capsules:
30

2)For soft capsules:
Weigh the capsules individually then cut and open the capsules
Remove the contents by washing with the suitable solvent
Allow the solvents to evaporate from the shells at room temp.
Weigh the individual shells
Calculate the contents
31

 Hard capsules containing 25 mg or more of the drug contents
should meet content uniformity requirements.
 The requirement is met, if the acceptance value of 10 capsules is
less than or equal to 15%. If acceptance value is greater than 15%
or is about 25 % then, test the next 20 capsules and calculate the
acceptance value.
 Assay 10 capsules individually and calculate the acceptance value.
Content uniformity:
32

Disintegration test:
The disintegration test determines the capsule disintegrate with a prescribed
time when placed in a liquid medium under the prescribed integral
conditions.
Method-
According to B.P. and which applies to both hard and soft capsules
1.introduce one capsule in each tube and suspend the apparatus in a beaker
containing 60ml water at 37°C,
- If hard capsule float on surface of water, the disc may be added.
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Dissolution test:
The dissolution test is carried out using the dissolution apparatus official
in both U.S.P and I.P.
The capsule is placed in a basket, and the basket is immersed in the
dissolution medium and caused to rotate at a specified speed.
The dissolution medium is held in a covered 1000ml glass vessel and
maintained at 37 °C. ±0.5°C by means of a constant temperature suitable
water bath.
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By measuring pre test & protest weights of pellet, amount can be calculated
Any change in color indicates absorption of moisture
Observe the dessicant pellet for color change
Expose the packaged unit to known relative humidity over a specified time.
The degree and rate of moisture penetration is determined by packaging the dosage unit
together with a colour revealing desiccant pellet
Moisture Permeation Test:
35

1.Leon Lachman Herbert A. Lieberman, The Theory
and practice of industrial pharmacy, Special Indian
Edition:2009 page no:296-302
2.N.K Jain, Pharmaceutical Product Development
Second Edition page no:105
Reference :
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