Contamination is a introduction of undesired impurities (such as chemical, microbiological or foreign matter) at different stage level of manufacturing, production, sampling, packaging, storage or transportation into the drug product.
Definition of cross-contamination in the pharmaceutical industry:
Cross-contamination is a contamination of starting material, intermediate or finished product with another starting material or a product during manufacturing process.
Sources of cross-contamination in the pharmaceutical industry:
Definition of Mix-ups in the pharmaceutical industry:
Mix-ups is inadvertently mixing of one thing to another. It is a mistake that results from taking one thing to be other.
Types of Contamination in the pharmaceutical industry:
2. Chemical contamination is due to API, intermediate, chemicals, and additives.
3. Physical contamination is due to Hairs, glass, paper, and real particles.
Sources of Contamination in the Pharmaceutical industry:
Impact of Cross-contamination and Mix-ups
2. Show cause notice
3. Loss of business
4. Warning letter
5. Production ban
6. Closure of premises also.
How to Prevent Cross-contamination in Pharmaceuticals?
There are multiple precautionary ways to prevent cross-contamination;
Sanitization and cleaning
What are the general precaution to perform Cleaning
- Before starting the manufacturing of drug product need to do line clearance and record it.
- Avoid more production at a time, only one product at a time is the best practice.
- Ensure to non-availability of previously manufactured product traces.
- Ensure proper line cleaning.
- Check the containers visually for cleanliness.
- Ensure validated systems are being in use.
- Avoid bare handling of the drug products.
- Clean and unclean material should be in separate places and shall be labeled.
- Do not keep the sample return to its original container.
Compressed Air precaution:
- Regularly check filters for cleanliness
- Regularly check filter integrity
- Use filtered air in the manufacturing area
- Steam is useful for cleaning, use a steam generator for cleaning
- Steam should be free from any foreign matters.
- Steam should be free from unknown matters which affect the production.
- Steam should be in proper condition, improper steam generator can produce contaminated steam.
- Ensure the reliable water source for the manufacturing of drug products.
- Ensure the proper microbiological and chemical levels.
- Regularly do the water testing for microbial growth.
- The water supply should be with proper channels.
- The person should wear proper clean dress and footwear
- Wash regularly aprons and linens.
- Regularly wash hands after using washrooms.
- Change clothing after every break
- Clothing in such way that covers full body
- Use separate cloths for every department
- Avoid exposure of own clothing and footwear
Sanitizing and cleaning precautions:
- Ensure sanitization of every area of manufacturing
- If spillage happened of any of the material batches shall be discarded
- Sanitize the equipment and label it as clean equipment.
- Airlocks should be in the place wherever required
- Proper hygienic practice shall be followed in the unit
- Pest control chemicals, cleaning agents, shall be away from the manufacturing area.
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