STERIS Helps EU GMP Annex 1 Compliance with New Sterilization Bags and Covers

Global provider of contamination control products and services, STERIS Life Sciences, has launched a new range of sterilization bags and covers, Verafit, aimed at helping companies to comply with the revised European Union (EU) good manufacturing practice (GMP) Annex 1 guidance. The product launch was announced in a March 25, 2024 press release (1).

The new Verafit bags and covers feature a polypropylene film window, which allows biopharmaceutical manufacturers an opening to both visually inspect and ensure the dryness of a sterilized part. Additionally, the bags and covers have been made with Purefit, flexible sterilization wrapping, to reduce contamination risk from particulates, microbes, or chemicals.

“When EU GMP Annex 1 was released, we recognized that many of our customers would need to visually confirm the dryness of a part within its sterile packaging,” said Elaine Sartain, vice president, Global Marketing, STERIS Life Sciences Contamination Control Products, in the press release. “Verafit Sterilization Bags and Covers make this possible via the viewing window. This enhancement adds to the overall value of our sterilization bags and covers, which provide an easy-to-use, consistent method of wrapping products and maintaining sterility.”

The EU GMP Annex 1 guidance pertaining to the manufacture of sterile medicinal products underwent an extensive rewrite and revision that lasted seven years and was subjected to a few rounds of consultation, seeing the guidance increase from 16 to 59 pages (2). The newly revised document was released by the EU in August 2022 (3) with it mainly—except for section 8.123 on product transfer and loading/unloading areas for lyophilizers—being enforced a year after publication in August 2023.

Revisions to the guidance document were made to reflect the various changes in the regulatory and manufacturing spaces, according to the GMP/GDP Inspectors Working Group and the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme Committee. As specified in the revised guidance document: “The new guideline should clarify how manufacturers can take advantage of new possibilities deriving from the application of an enhanced process understanding by using innovative tools as described in the ICH [International Council for Harmonisation] Q9 and Q10 guidelines.” (3).

Additionally, in June 2024, STERIS Life Sciences will host an educational event covering a variety of contamination control topics, including EU GMP Annex 1. The event will be held in the Marriott Hotel in Frankfurt, Germany (4).

References

1. STERIS Life Sciences. STERIS Introduces Verafit Sterilization Bags and Covers to Support EU GMP Annex 1 Compliance. Press Release, March 25, 2024.
2. NSF. What You Need to Know About the Annex 1 Revision. Nsf.org, Knowledge Library (accessed March 27, 2024).
3. European Commission. The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. Annex 1: Manufacture of Sterile Medicinal Products. EudraLex Volume 4, Aug. 22, 2022.
4. STERIS Life Sciences. Advanced Concepts in Cleaning Validation and Process Optimization. Two-Day Event, Frankfurt Marriott Hotel, Germany, June 5–6, 2024.

Source: STERIS Life Sciences