General requirements:
- The machines are completely closed.
- All materials in contact with product are in stainless steel or plastic.
- No part of the machine above the product is painted.
- The steel surfaces are not painted.
- Aluminium, where used, is hard anodized.
- All surfaces of feeding systems in contact with the product are rimmed and polished.
- There are no sharp edges.
Clean room applications:
- Easy-to-clean design.
- All surfaces are smooth and easy to clean.
- All the solutions adopted are such as to avoid electrostatic charge on the components and products.
- Feeding systems without blowing air.
Documentation & validation:
- In accordance with 21 CFR Parts 11:
– Centralized security system (Custom Access).
– Automatic distinction between the functions.
– Standardised reporting system.
– Traceability of all operations. - Validation of the machine in accordance with GAMP5.
- Protocols DQ, IQ and OQ.