- Which official requirements must be observed when designing rooms in accordance with the EU GMP Guide and the U.S. cGMP regulations?
- What is the significance of the personnel flow and material flow in production?
- Which design concepts does FDA recommend for an aseptic processing facility?
- How can the requirements for the different room grades be met?
- What details must be observed when designing rooms for pharmaceutical purposes?
- What has to be taken into account during installation of building services in clean rooms?
- What is the objective of qualification of premises and air-conditioning systems?
- Which physical and microbiological parameters require monitoring?
Table of contents
Material flow, personnel flow and layout
Barrier systems and isolators
Heating Ventilation Air Conditioning(HVAC)
Qualification of premises and airconditioning systems
Monitoring of HVAC systems
This article is a download product! Please note the following procedure guidelines:
If you choose payment by bank transfer:
- You will receive an advance invoice.
- After payment is received an email with the download information will be sent.
If you choose payment by credit card:
- You will receive an email with the download information immediately after the credit card payment.
- The invoice will be sent by postal mail as soon as possible.
PDF file for download