Good Health Capsule
The capsule contains essential minerals, vitamins, and other nutrients for good health. The capsules are manufactured for boosting the immunity as well as to increase the level of energy. The capsules are very convenient dosage forms and also very easy to intake daily as compared to other dosage forms. The capsules are recommended to those individuals who don't want to take other solid oral dosage forms such as tablets.Read more - Capsules - What kind of pill is a capsule
In-Process Quality Control (IPQC) for Capsules
There are the following types of steps which is important while performing the in-process quality control test for capsules. It includes;Step 1- Manufacturing of gelatin shells
Step 2- In controlled humidity drying of shells
Step 3- Granules manufacturing
Step 4- Filling of shell
Step 5- Packaging and labeling of the hard gelatin capsules
Read more - What are 4 types of capsules
IPQC Checks During Gelatin Shell Manufacturing
A few steps are necessary to inspect during gelatin shell manufacturing.1) Percent purity of the gelatin.
2) The viscosity of the gelatin solution should be 25-45 millipoise.
3) The bloom strength of the gelatin solution should be 150-250 gm.
4) The Iron content is not more than 15 ppm.
5) Thickness of the film should be checked.
6) The moisture content should be in the range of 12-15%.
7) Body of the shell as well as the length of the capsule should be checked.
8) For drying of shells temperature of hot air should be maintained.
9) The color, surface, as well as appearance of empty shells, should be checked.
Read more -Hard Gelatin Capsules | Manufacturing Methods
- Hardening of shells and softening of shells
- Discoloration of shells
- Misprinting of logo on shells
- Swelling of shells
- Cracking of shells
Finished Product Quality Control Test of the Capsule
Appearance
Capsules should be uniform in appearance.For the detection of any defect in the appearance of capsules, visual as well as electronic inspection should be done.
Size and Shape
Hard gelatin capsules are formulated in a variety of sizes.The sizes for human use which is ranges from 000 (the largest) to 5 (the smallest) are available. Inspection should be done for shape and size.
Read more -Soft gelatin capsules
Unique Identification Markings
For better identification, hard gelatin capsules may be printed with either symbols or other unique identification markings.Uniformity of Weight
There are the following types of steps involved.Step 1- Weigh an intact capsule
Step 2- Open the capsule shell without losing any part of the shell and remove the contents completely.
Step 3- To remove the contents of a soft capsule the shell may be washed with ether or other suitable solvent and the shell allowed to stand until the odor of the solvent is removed completely.
Step 4- Again weighed the shell and noted the differences of weight of the contents in the weighings.
Step 5- Repeat the procedure for further 19 capsules.
Step 6- Now, calculate the average weight of the capsules.
Step 7- Not more than two of the individual weights deviate from the average weight of capsules by more than the percentage deviation and no one deviates by more than twice that percentage.
Percentage Deviation
| Average weight of capsule contents | Percantage deviaton |
|---|---|
| Less than 300 mg | 10 |
| 300 mg or more | 7.5 |
Uniformity of Content
The content uniformity is performed on the capsules that contain less than 10 mg or less than 10 percent w/w of the active ingredient.To determine the content of active ingredients 10 capsules were taken randomly.
The capsules passed the test if not more than one of the individual values obtained is outside the limits 85 to 115% of the average value and none is outside the limits 75 to 125%.
If two or three individual values are outside the limits then again repeat the test with 20 capsules until the limit is achieved which is specified in the monograph.
Disintegration
For hard gelatin capsules and soft gelatin capsules, for which the dissolution test is included in the individual monograph, the test for Disintegration is not required. The disintegration test does not apply to Modified-release Capsules.a) Hard Gelatin Capsules
As per the standards, water is used as a medium.A disc may be added if the capsule floats on the medium surface.
Attach a removable piece of stainless steel woven gauze with a mesh aperture of 2.00 mm to the upper plate of the basket rack assembly and carry out the test omitting the discs, If the capsules adhere or stick to the discs.
The apparatus should be operated for 30 minutes as directed as per the standards.
b) Soft Gelatin Capsules
As per the standards, water is used as a medium and a disk is added into each tube so that Capaule does not flow out of the tube.As given in the standards, operate the apparatus for 60 minutes.
Read more - Soft gelatin capsule manufacturing
Read more - Pellets
c) Enteric Capsules
By using these capsules in each tube and operate the apparatus for 2 hours without the discs in 0.1 M HCL (hydrochloric acid).None of the capsules shows any rupture or disintegration which allows the content to run away from the capsule.
Now, change the medium in the vessel with mixed phosphate buffer of pH 6.8 and add a disc to each tube and again operate the apparatus for 60 minutes more.
Then remove the apparatus from the medium and inspect the capsules.
If no residue remains on the screen as well as the underside of the discs then they passed the test.
If there is any residue or soft mass or fragment of the shell then it fails the test.
Content Uniformity of Drug
A 30-capsule sample is taken 10 are assayed individually.The content of the drug in the capsules should be within the limits of the average drug content which is ±15% and the drug content of none of the capsule fall outside the average drug content which is ±25%.
If 1 to 3 capsules fall outside the range of average drug content that is ±15% then the remaining 20 are assayed.
The drug content of at least 27 out of 30 assayed should be within the average drug content +15% limits and none of the capsules falls outside of the limits.
The test is performed for the capsules when the active ingredient is less than 10 mg or 10% of the filled weight.
Dissolution Test
The dissolution test is performed by using the dissolution test apparatus as per U.S.P.The capsule is placed into the basket.
The basket is dipped into the dissolution medium.
Now, the basket is rotated at a specific speed as per standards.
The dissolution medium is placed into a 1000ml covered glass vessel at a constant temperature water bath of about 37°C ±0.5°C.
Acceptance Criteria for Dissolution Study
| Stage | Number of capsule tested | Acceptance criteria |
|---|---|---|
| S1 | 6 | Each unit is not less than Q + 5% |
| S2 | 6 | Average of 12 units (S1+S2) is equal to or greater than Q, and no unit is less than Q - 15% |
| S3 | 12 | Average of 24 units (S1+S2) is equal to or greater than Q, not more than 2 units are less than Q - 15%, and no unit is less than Q - 25% |
Manufacturing Defect of Hard Gelatin Capsule
Various types of defects occur while manufacturing the hard gelatin capsule. It includes;
1) Sometimes the surface of the shell does not become smooth.
2) Sometimes transparency (opacity) is not achieved as per the requirement.
3) Sometimes Capaule remains empty after the filling stage
4) Capsules also lose their integrity due to pinholes, crackers, or breaks.
5) Some times surface of the capsule shell gets spotted as well as embedded particles on the capsules.
6) Capsules are non-uniformity in appearance as well as are not of the specified type of color variation.
7) While filling out the capsule times uniform fitting is not occupied.
8) Sometimes foreign matter may also come inside the shell during filling the capsules.
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