Are Sterile Bioprocess Containers A Source Of Particulate Contamination? (Part 2)

 

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Where Does Particulate Come From?

 

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Particulate matter consists of mobile, random extraneous substances from a variety of sources. Corrugate and plastic particulate are common, but we have seen other materials including talc, debris from cap liners, glue and even hair!

 

Contaminants also arise directly from the molding process; EBM is especially prone to generation of particulate. Necks are cut rather than injection molded and there is frequently a trimming/finishing operation associated with the neck and ‘tail’ (extra plastic at the bottom of the container). EBM containers are prone to “flash” and “stringing” around the neck and seal area of the bottle. This can often be found as particulate in containers.  In addition, high pressure air, used to form containers in all molding operations, can be a source of contamination if not filtered to a level meeting particulate standards.

Overall, product cleanliness is impacted by:

  •  The environment for container molding and capping;
  •  Component storage conditions for items not immediately used and packed;
  •  Cleanliness of the packaging environment;
  •  Effectiveness of housekeeping and cleaning protocols;
  •  The level of machine, mold and facility maintenance;
  •  The effectiveness of personnel training.

The Implication Of Particulate In Your Production Process

Introduction of particulate into a biopharmaceutical or vaccine manufacturing process should be avoided. GMP dictates that all possible steps should be taken to prevent particulate contamination instead of relying on contamination removal during final processing. The presence of particulate, due to its random nature, indicates poor process definition and lack of control over the production process.

At a worst case, particulate contamination could put patient health at risk. More likely, it could lead to a costly production shut-down and a time-consuming investigation by internal or by external agencies; potentially even a product recall. The financial risks are severe.

Cost, Benefit And Risk

Sterile, ready-to-use containers have proven a successful alternative to in-house cleaning and sterilization of containers but they still pose a significant risk. Certified clean, sterile containers are available at negligible costs when compared to the risks associated with uncertified clean containers.

Coming next, Part 3, USP 788 Certified Containers Reduce Contamination Risk.

 

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