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Preventing Cross Contamination In Pharmaceutical Production Process

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There are several ways to prevent cross contamination during the production of pharmaceutical products. The list below is a guide to help minimise cross contamination between products.

General

  • Before starting, line clearance should be performed as per the standard operating procedure (SOP) of the company. Use a checklist and record that clearance has been completed.
  • Check to see if any starting materials are missing, check that previous record documents are complete and there are no previous product residues or product itself remaining.
  • Practice a closed system when handling the materials (i.e., do not handle more than one set of materials at a time).
  • Do not process more than one product in the same area during production.
  • Check that every material is free from microbial or any other form of contamination.
  • Before using, remove the outer wrapping of the packaging material to help reduce contamination.
  • Before filling, visually check to see if the containers are clean.
  • Packing should be carried out with physical space between the packing lines.
  • Ensure proper and validated production system is in place.
  • Do not handle with bare hands the product or any items of equipment that will be in contact with the product.
  • Process control can be done in the production area but it must be cleaned to prevent any contamination of the product.
  • After production, follow the protocol for cleaning and maintenance of the equipment ensuring that the appropriate cleaning materials are used.
  • Cleaning materials should have labels on them to ensure that they can be clearly identified, and are different from that of the product.
  • Products that are identified for special circumstances should be reintroduced only when investigation and clearance is provided by the authorized personnel. All incidents should be recorded.
  • Repair and maintenance of the equipment should not have any impact on the quality of the product.

Clothing

  • Personal clothing should be of high quality. It should be appropriate and acceptable in the work area.
  • Opt for linen, as this is a non-shredding type of material.
  • Wear clothing that lessens or minimizes the exposure of body parts.
  • Routinely wash your hands.
  • It is important to wash clothes that have come in contact with sensitive products separately from other clothes.
  • Clothing should not be exposed to or contaminated by cleaning agents.
  • Use appropriate personnel protective equipment when applicable.
  • Use dedicated protective equipment for antibiotics, beta lactum, cytotoxic, hormones and drugs that are manufactured using live microorganisms.
  • Change clothing after every product change or breaks.
  • Guidelines for cleaning footwear should be provided.
  • Regular environmental monitoring of particle count, active air sampling and settle plate count should be carried out.
  • Clothing is preferred that is able to be worn repeatedly or that can be laundered repeatedly without deteriorating.

Utilities

  • Water should be appropriate for use in the manufacturing of pharmaceutical products. Regular checks should be made on the quality of any bulk supplied water (tap water)
  • Chemical and microbial limits in the water should be appropriate for the intended use.

Steam

  • Use a steam generator whenever possible for cleaning.
  • Steam should be free of additives.

Compressed Air

  • Use filtered air and ensure that the filter is regularly checked and replaced, as per SOP.

Sanitation and cleaning

  • It is important to practice proper hygiene and sanitation controls in every level of the manufacturing process.
  • Cleaning materials, pest control chemicals and sprays, chemical solutions and equipment lubricants should not come in contact with the product. Use suitable products to minimize the risk.
  • Prevent cross contamination by carrying out regular maintenance of equipment as per the company guidelines.
  • Products that contain beta lactum, hormone, cytotoxic and antibiotics should be packed in a dedicated area or at least in different area to other products.
  • Active raw materials of beta lactum and similar can be transported with other active materials, the packed finished products can be transported with other non-active finished product.
  • If spillage or contamination occurs, discard the whole batch.
  • It is important to label containers clearly. This includes containers for raw materials, in-process and partially processed materials.
  • Label any empty containers with ‘cleaned’ or ‘to be cleaned’. Also label any empty containers with what previous product was placed in the container.
  • If beta lactum, cytotoxic, hormone or antibiotics are manufactured with other products in the same building it is vital to ensure that cross-contamination is prevented. Ideally this should be done by using a separate facility or dedicated machinery or equipment for the different products.
  • Use air locks or air extraction when needed.

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