Control of Contamination at Different Manufacturing Stages : Pharmaceutical Guidelines

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Control of Contamination at Different Manufacturing Stages

Contamination control is most important part of the pharmaceutical manufacturing because contamination is everywhere in the atmosphere and a little carelessness can contaminate the pharmaceutical products.
One of the most critical aspects of dosage form manufacture is the vigilance and care required ensuring the complete absence of any form of cross-contamination. Contamination may occur at any stage of the manufacturing process. Personnel, equipment, area and raw material all may have contamination that can contaminate the whole batch.

Different controls at the various stages are:
1. Procurement: The purchase and quality control department conduct a systematic vendor evaluation. This includes a detailed inspection of the supplier's factory, the main purpose of which is to identify any potential source of cross-contamination of substances supplied. If the manufacturing location is manufacturing more than one item, periodically the QC department shall attempt to identify the presence of the contaminant in the item purchased.

The procedure followed in the production of packing components, particularly the intimate packaging items (bottles, PP caps etc. ) is carefully studied by the QC team, essentially with a view to tracking any residual contaminant e.g. mold, lubricant, metal filing etc.

Contamination Control

2. Receiving and Storage: The staff responsible for clearing and forwarding is to be 'educated' on the importance of inspecting the cargo to identify if there is any evidence of contamination. There is a very strong possibility of improper storage, whereby, material purchased is accidentally contaminated by the contents of other containers leaking or spilling. Attention needs to be paid in the transporter's warehouse and the customs hold area. A similar vigilance is required to be exercised by all personnel responsible in the company for storage at different stages/locations.

Periodically the statutory agencies, particularly the import control department requires samples to be drawn. Unless these samples are drawn carefully in controlled conditions, a potential contamination hazard exists. It is essential to request assistance from QC personnel for such sampling. The store's personnel shall verify with QC suitability of containers if the contents from the original container are required to be transferred.

3. Dispensing: Dispensing of the material should be done carefully under the dispensing booth to protect the material from contamination. Dispensing equipment must be cleaned and free from contamination. The SOP for the dispensing of materials needs to be religiously followed to prevent any cross-contamination.

4. Compounding: Apart from the prescribed SOPs, supervisors concerned should pay attention to the condition of garments worn by the operators and the cleanliness of the various accessories, including scoops, spatulas etc. Particular attention is required to ensure that the crevices, gaskets etc. are free from any contaminant. Dust control equipment must invariably be validated to confirm its capability to pick up materials. Periodic chemical testing of the rinse from cleaned equipment can further increase the confidence of cross-contamination control.

5. Processing: These areas should be secure and accessible only to the authorized personnel. Sampling can be carried out only by and under instructions from the technical manager or authorized personnel. Standard Good Manufacturing Practices (GMP) and routine sanitary control and inspection can eliminate potential hazards. Prolonged hold needs to be discouraged or eliminated.

6. Packaging: Packaging should be controlled and contamination free. Packaging operators should be well trained to prevent contamination during the packing process. SOP must be followed strictly during the intimate packaging to protect the product from any cross contamination.

The above is only explanatory guidelines and through understanding and committed observance of prescribed procedures that we can produce a product without contamination.





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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