HVAC Clean Rooms Validation Documents

PREPARATION OF VALIDATION DOCUMENTS FOR CLEAN ROOMS

Complete Documentation for Clean Rooms in Accordance with Applicable Standards

In the course of 2008 Termovent trained its engineers for preparation of complete validation documentation (VP, IQ, OQ…) as well as for implementation of validation documents in the installed HVAC systems in accordance with the applicable GMP, FDA and GAMP standards. The training was carried out in the accredited company CHEMGINEERING (Vienna, Austria). 
 
Termovent Engineering provides preparation of the following validation documents:

General Documents

  • FDS (Functional Design Specification)
  • TDS (Technical Deign Specification)
  • EQL (Equipment List)
  • FL (Filter List)
  • PCI (List of Process Critical Instruments)
  • CTP (Cleaning and Transport Protocol)
  • TP (Training Protocol)

Manuals and certificate

  • MM&CF (Manufacturer’s Canuals and Certificate)

Automation

  • EQL/ Automation
  • CL (Cable List)
  • IOL (IO List)
  • CD (Circuit Diagram)
  • FDS (Functional Design Specification)
  • HDS (Hardware Design Specification)
  • SDS (Software Design Specification)
  • SCADA (User Manual for Scada)
  • AL (Alarm List)
  • PL (Parameter List)

AS build drawing

  • P&ID, Ductwork, HEPA filter position plan, Disposition of Equipment, …

Commissioning tests

All Commissioning Tests are carried out on the basis of an agreed validation plan.

Qualification Documents

  • IQ (Installation Qualification Protocol)
  • OQ (Operational Qualification Protocol)
  • IQ/OQ APPENDIX (texts, graphics, appendices)
Clean Room Specialists
Clean Rooms are specially constructed, environmentally controlled enclosed spaces, where particles of a size 0.3 microns and larger have negative impact on production process. They are widely used in semiconductor manufacturing industry, pharmaceutical, medical devices and biotechnology production, and similar.
Clean rooms catalog
Clean Rooms Catalog (PDF)