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3 ways to address sterility assurance requirements of the EU GMP Annex 1

28 November, 2022 | ChargePoint Technology

Learn about the three key steps companies need to take to meet the EU GMP Annex 1 sterility assurance requirements

The latest issue of Annex 1 of the EU’s Good Manufacturing Practices (GMP) for the manufacture of sterile medicinal products has now been released. Coming into effect in August 2023, manufacturers now needs to take action. There are a number of considerations to the way drug developers and their CDMO partners handle their products and solutions to ensure sterility assurance.

We’ve broken down the three key proactive steps companies need to take to help meet the incoming Annex 1 sterility assurance requirements before they come into effect:

1. Implement a Contamination Control Strategy (CCS)

Annex 1 revisions requires drug manufacturers to implement a Contamination Control Strategy (CCS). A CCS is a formally documented action plan, which examines a holistic, systematic set of control mechanisms within a cleanroom environment. Subject to regular review, this strategy aims to provide a high degree of assurance of elimination of contamination in the finished product.

From the cleanroom design to processes in place, from risk assessment to validation procedures, a CCS takes into account many aspects of contamination control, including:
– The design of the environment and its processes
– Equipment used in the facility
– Personnel training and gowning
– Cleaning and validation
– Environmental monitoring
– Prevention testing through process simulations

2. Future-proof your cleanroom environment with closed systems

The use of closed systems reduces the risk of microbial, particulate or chemical contamination from the operating environment. The following fundamental considerations for how the Aseptic SBV meets the requirements of the Annex:

  • Interventions should be reduced or eliminated
    The use of a closed transfer system can be considered to reduce the need for manual interventions. An Aseptic Split Butterfly Valve is inherently utilising the principle of serparation to provide a barrier between the product and the cleanroom environment and its potential sources of contamination. The use of automation is possible to remove indirect human intervention both either within the cleanroom or inside a RABS or Isolator system with robotics.
  • Aseptic connections should be sterilisable in place
    Aseptic connections such as this should be either sterilisable in place or performed under Grade A conditions unless intrinsically validated. The Aseptic Split Butterfly Valve product contact surfaces are designed to be steam sterilized in place prior to material transfer. The use of Vaporised Hydrogen Peroxide (VHP) as a non-product contact decontamination of exposed mating surfaces results in an overall repeatable, validated transfer method that allows the transfer to take place in a sub-Grade A environment or in a grade A environment where first air cannot be guaranteed around the process.

Using aseptic SBVs as part of a robust CCS process will allow you to perform validated direct aseptic powder transfers while also ensuring the safety of personnel if handling toxic drug products.

3. Streamline processes with single use alternatives

The latest revision acknowledges the advancements that have been made in sterile processing technology that can help companies achieve sterility assurance. Aseptic SBVs are one such example, but companies can go even further in achieving optimum compliance while maximising efficiency by using Single Use System (SUS) alternatives.

Pharma companies have increasingly turned to SUSs to get around the extra cleaning and validation steps between uses. Validated, pre-sterilised SUS versions of the SBV with combined bag technology offer the same sterility assurance as their stainless steel counterparts, but by disposing after use pharma companies can sidestep the need to clean and validate between uses.

Regardless of their potential benefits, the supply of these SUSs must address several risks including but not limited to: integrity; particulate contamination; sterilisation processes; robustness; extractables and leachables.

This helps further reduce the risk of contamination between cleaning campaigns and offers greater flexibility and time savings across the product transfer process.

Get ahead of new Annex 1 guidelines and assure uncompromised sterility with our Aseptic Split Butterfly Valves.