In the new Annex 1 there are several changes which must be observed particularly by planners, installers and service providers for the clean room (room, lock concepts and barrier systems), air routing, qualification and requalification.
Some points from Annex 1 mainly concern plant technology (air-conditioning technology), room planning (lock concepts) and the qualification, requalification of rooms for the achievement and verification of the necessary protective targets for aseptic manufacturing. All measures must be coordinated based on risk. The operating company must choose one way of achieving the necessary product protection, taking the following factors into consideration amongst others:
- Risk for the product
- Risk for the operator and the environment
- Effectiveness of the production process
- Energy requirements

Annex 1 has tightened up many points, defined them in more detail and, unfortunately, brought up new questions.