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Cleaning & Process Validation

There are health and safety implications involved with reusing manufacturing lines for biopharmaceutical products.

Regulatory agencies seek to ensure that manufacturers that do reuse manufacturing equipment for multiple product lines keep consumer safety to-of-mind. Consequently, they have enacted regulatory standards that biopharmaceutical manufacturers must meet to bring their products to market.

Regulations demand that product lines be cleaned to a strict standard prior to manufacture drugs from a different pharmaceutical formulation. The processes used to clean the lines must be validated in advance of releasing pharmaceuticals to the market.

Cleaning Validation Methods

Our expert scientists and chemists must first break down the pharmaceutical manufacturing environment and its cleansing procedure by identifying the chemical components of the cleaner as well as the excipients, active pharmaceutical ingredients (APIs), decomposition products, and preservatives in the drug product.

Samples are taken using the rinse water sampling method, swabbing, or coupon sampling.

  • The rinse method allows analysts to characterize all the chemical substances present in a water sample of an equilibrated post-final rinse recirculated over all surfaces in the environment.
  • The swab method uses a wipe or swab moistened with highly purified water to pick up chemical substances from a defined area systematically.
  • The coupon method dips sample coupons into high purity water that extracts residues.

Measures of total organic carbon (TOC) and pH conductivity help meet requirements enacted by regulatory agencies. By providing documented evidence that a manufacturing facilities cleaning methods can reliably control carryover of APIs, extraneous materials, and cleaning agents into a subsequent product, biopharmaceutical producers can create medicines that consistently avoid contamination.

It’s important to the future of medicine – research and development for pharmaceuticals is inherently costly, and any way that developers can find to reduce the overhead cost of manufacturing useful drugs and bringing them to market will ensure that they can continue to pour resources into improving and crafting new drug formulations.

But consumer safety is still paramount, and the thorough cleaning validation assistance provided by the experts at Avomeen can help you meet regulatory requirements while simultaneously enabling you to refine manufacturing processes to keep costs low.

Want to know more? Check out our Cleaning Validation Whitepaper.

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