All about how to clean those sterile mixing vessels

Posted by Aesha Ahuja on March 20th, 2020

Cleaning validation is the process where pharmaceutical production equipment is cleaned effectively. This process happens in the pharmaceutical industry to avoid cross contamination and adulteration of drug products. The main purpose of doing this is to ensure that the company is complying with a particular set of standards and rules. This is very important because it helps to identify and rectify issues with the machinery that might have gone unnoticed previously. One cannot compromise on safety, quality or efficacy of drug produce which is why having sterile vessel almost becomes a necessity.

Special attention should be paid to ‘difficult to reach’ surfaces. Cross contamination in the pharmaceutical industry will multiply several problems that could have been otherwise dealt with. One must usually follow a step-by-step evaluation method to determine the best way of resolution. If they were to be listed down, cleaning validation for sterile filling vessels is necessary because: 

1. It fulfills the most basic need of the customer, that is purity and safety.

2. It is a standard requirement of the Active Pharmaceutical Ingredient Product manufacture.

3. The quality of the process is assured through internal compliance and control.

However, what are these contaminations in sterile mixing vessels that we keep talking about? 

1. The contamination that happens when the current batch of pharma product mixes up with the residual remains of the previous batch that was in that vessel.

2. The contamination that happens when the otherwise safe ingredients and drugs used for human consumption come in contact with unintended materials that are a part of the equipment directly or indirectly; through brushes, rags, chemical cleansers, etc.

3. The contamination that happens due to the conditional surroundings and environment.

The process of cleaning validation must fulfill certain Food and Drug Administration requirements that are:

1. Firms should have a written Standard Operating Procedure (SOP) that details the cleaning process employed for various parts of the equipment.

2. Whatever cleaning procedures, rules, intervals between two processes may be, the FDA expects written procedures that address these different issues.

3. The personnel responsible for handling the cleaning should be aware of the procedure and must strictly comply with the rules.

4. Each firm should make sure that there are protocols of use and crisis management attached to each machine.

5. The firms must conduct all their operations in accordance to the protocol and records the results of their study.

6. There must be a final validation report which is approved by the FDA regulatory board and that is the final stamp of approval.

There are also certain testing methods that must be followed to see if the cleaning validation process is happening how it should:

1. It should have the ability to detect target substances when they are consistent with the acceptance criteria.

2. it must also have the ability to detect substances among other substances that may be present in the mix.

3. The testing method should also include a method of calculation that converts the amount of residue detected in the sample.

Cleaning validation also includes sampling techniques, of which there are usually two. One is the direct surface sampling which involves the finding out of which type of sampling material is used and its impact on the test data. Another is the swab sampling where swabs are touched upon the surface to check the cleanliness.