Aseptic Manufacturing

Safety First.  That’s the mantra echoed across almost every industry in the world.  This is especially true in the life sciences industry.  But this safety takes many forms.  The first and foremost is patient safety, the final customer.  For sterile parenteral products, ophthalmic solutions, and medical devices; product sterility is of the upmost importance.  Sterility is achieved in multiple ways, a few of which include:

  • Sterile Filtration
  • Terminal Sterilization through Autoclave or Dry Heat Ovens
  • Gamma Irradiation
  • Chemical Sterilization (e.g., Ethylene Oxide or “ETO”)

For some products, Gamma Irradiation or Chemical sterilization is most appropriate, as they can withstand any potential conformational changes that are a known challenge with those types of sterilization.  For many products though, sterility can only be feasibly achieved through sterile filtration.  For parenterals, aseptic filling operations and the associated aseptic technique are some of the most critical operations performed in the manufacturing process.

Aseptic Technique is a not only the specific maneuvers that can and cannot be made in an aseptic manufacturing area, but a mindset for every member of the manufacturing and QA team.  Every aspect of manufacturing must be critically assessed against key principles.  These principles include:

  • Protecting the First Air
  • Maintaining the aseptic area through gowning, disinfection, and laminar air flow
  • Acting within the existing bounds of the qualified Aseptic Process Simulation

Aseptic Technique is the critical line between product that is safe to put on the market, and a product recall.  A breach of aseptic technique represents a huge risk to the product, and to patient safety.  It calls into question the product quality and safety, and if not created and maintained effectively, can cause a negative impact both financially and through sullying the company reputation if 483’s, Warning Letters, or recalls are a result of a lack of aseptic technique.

Kymanox has specialized expertise in Aseptic Process Simulation and Aseptic Technique, and has helped companies struggling with these aspects of their manufacturing operations to get their systems established, validated, and safely aseptically manufacturing product.