The newly updated Annex 1 is intended to provide legally binding guidance for the manufacture of sterile products.
Whereas apparel is generally thought of as being required to protect both personnel and the environment, in addition, Annex 1 states that apparel must be worn in such a way as to ‘protect the product from contamination’ (Part 7.11). We know that humans are the primary source of contamination and so establishing an aseptic gowning program is essential.
The required apparel is dependent on the classification of your working area; Annex 1 recommends the following for each classification:
Grade A / B
Grade A signifies a critical area for high-risk operations or for making aseptic connections by providing initial air protection. Its background, Grade B, represents its preparation area. The revision of Annex 1 stipulates the following requirements in these areas:
- Use dedicated garments worn under a sterilised suit
- A sterile headwear which must enclose all hair (including facial hair)
- Sterile face masks
- Sterile eye coverings such as goggles that should fit the around the face
- Powder-free rubber or plastic sterile gloves*
- Sterilised footwear, such as over boots, clogs and shoes
- Use dedicated cleanroom socks
Grade C / D
Grade C/D signify cleanrooms used for less critical stages in the manufacture of aseptically filled sterile products though may be used for the preparation/filling of terminally sterilized products.
- Cover hair, beards and moustaches with a beard snood
- Operators must wear single or two-piece trousers and high collar tunics (in
- grade C) and general protective suit (in grade D)
- Use a dedicated cleanroom sock in a Grade C cleanroom
Our expertise and knowledge within the pharmaceutical industry have led our team to develop an extensive range of products to meet the requirements of Annex 1 and assist you with the challenges this new revision brings.
For more information on Annex 1, please click the link below.