Adherence to the cGMP Guidance

Specification, Documentation & Acceptance Testing

In general, Tuttnauer adheres to the cGMP in order to satisfy your requirements for documentation and qualification of pharmaceutical autoclaves.

In order to give our customers the confidence that they are using safe high quality cGMP pharmaceutical autoclaves, Tuttnauer comprehensively documents the design specifications, components, software, manufacturing process, and acceptance testing in order to prove that the autoclaves meet the customer’s requirements.


In order to ensure quality manufacturing, Tuttnauer applies GAMP guidelines at various stages of the manufacturing process.

Acceptance Testing

Tuttnauer has an advanced testing laboratory for acceptance testing of each autoclave before it leaves the factory. Each autoclave is subjected to Factory Acceptance Testing (FAT) which includes IQ - OQ documentation. In order to facilitate site validation, Tuttnauer provides a Site Acceptance Testing (SAT) service which includes IQ - OQ documentation.

Deliverable Documentation

Depending on customers requirements the following documentation can be supplied:

  • DQ, IQ, OQ (including document templates for SAT)
  • List of materials and components (with ID tagging)
  • Data sheets and certificates for components and subsystems
  • Certification of calibration
  • Conformity certification
  • Dimensions and location drawings
  • Installation instructions
  • Operations/technical manual

Standards and Directives

Tuttnauer manufactures autoclaves according to necessary international and local standards/directives required by our customers.
cGMP | FDA for LVP and SVP | GAMP | BPE2009 | ISPE BASELINE GUIDES | ISO 13845 | ISO 9001 | 21 CFR Part 11 | UL61010A ASME Code | ISO17665-1 | EN 285:2006

Control & Documentation

Features and Options

Standard         Optional o

Validation and Support Documentation
IQ/OQ Documentation (cGMP)
DQ Documentation
Software Sequence of Operation (SOO) o
FAT (Pre-qualification) o
21 CFR part 11 
Independent Recorder o
10” Touch Screen (7” standard) o
External Printer o