Print Page | Contact Us | Sign In | Register
Online Store: Publications
Main Storefront

PHSS Technical Monograph No 20 Bio-contamination

Item Options
Sign in for your pricing!
Price: £175.00
Status: In Stock (22 left)
Quantity: *


Newly released!

A comprehensive review and best practice guidance:

Bio-contamination Characterisation, risk profiling, control, monitoring and deviation management.

Prepared by a PHSS special interest group from the pharmaceutical industry, NHS, Suppliers and specialist consultants.

Reviewed by the MHRA.

Applies to controlled environments in GMP and non sterile applications where  Bioburden control is required.

Overview of content
Section 1. Introduction and scope includes a review of the challenges and requirements for Bio-contamination control and cross contamination control with a holistic approach to monitoring and proactive investigations in
response to increased risk from changes in biocontamination profiles.

Section 2. Bio-contamination characterisation and risk profiling. Methodologies and strategies that profile bio-contamination through establishing control, in operations and holistic monitoring.

Section 3. Bio-contamination control principles and best practice guidance considering Quality by Design, different processes, control attributes background environments and Barrier technologies.

Section 4. Bio-contamination monitoring including classical and Rapid Micro Methods (RMM).

Section 5. Bio-contamination Deviation management including considerations and guidance in completing investigations and undertaking corrective and preventative actions (CAPA).


6a Kingsdown Orchard, Hyde Road Swindon, Wiltshire SN2 7RR UK

tel: +44 (0) 1793 824254 email:


This website uses cookies to store information on your computer. Some of these cookies are used for visitor analysis, others are essential to making our site function properly and improve the user experience. By using this site, you consent to the placement of these cookies. Click Accept to consent and dismiss this message or Deny to leave this website. Read our Privacy Statement for more.