Adherence to the cGMP Regulations
Specification, Documentation & Acceptance Testing
To ensure that our pharma autoclaves satisfy your requirements we implement a strict documentation and qualification process according to cGMP regulations. This process starts with defining specifications and expectations which will impact every aspect of manufacturing.
Deliverable Documentation
Our cGMP documentation process is an integral part of each stage of the project management and manufacturing process. The following is a partial list of documentation that we provide:
Order Related Documentation
- URS and Compliance
- Commercial Order Documentation
Design Qualification (DQ)
- Pressure vessel design (ASME/PED)
- Layout drawing
- General drawing
- Piping and Pneumatic drawing
- Electrical drawings
- Accessories drawings
- Software Requirements Specification (SRS)
Installation Qualification (IQ)
- Chamber radiology testing
- ASME/PED certificate
- Surface finish reports
- List of materials and components (with ID tagging)
- Sanitary piping and component certificates
- Datasheets
- Orbital welding video reports
- P&ID
Operation Qualification (OQ)
- Certification of calibration
- Validation and test reports
Manuals
- Installation instruction
- Operation manual
- Maintenance manual
- Technical manual
Acceptance Testing
Each autoclave is subjected to a strict examination in Tuttnauer’s advanced testing laboratory. Following our internal testing, we invite the customer to conduct a Factory Acceptance Testing (FAT) which includes DQ, IQ , OQ review. In order to facilitate site validation, Tuttnauer provides a Site Acceptance Testing (SAT) service which includes review of documentation, installation and operation of the autoclave.
