microbial impactor Articles | Environmental XPRT

Table of Statistical Corrections According to Feller for the BioCapt® Microbial Impactor in Microbial Air Sampling

Abstract This application note uses the principle that, as the number of viable particles — colony forming units (CFUs) — impact on an agar plate increases, the probability that viable particles will enter unoccupied space decreases. The values within Tables 1 and 2 are shown at flow rates of 25–50 LPM and 100 LPM. BioCapt microbial impactors are used on all Particle Measuring ...

May 18, 2019

By Particle Measuring Systems

What are the newest Annex 1 Single use Requirements and does the BioCapt Single use Impactor meet them?

The new EU GMP Annex 1 rev 12 states, regarding single use: Chapter 8 . Production and Specific Technologies Paragraph : Single use systems (SUS) Annex 1 rev Dec 2017 – (8.117): Single use systems (SUS) are those technologies used in manufacture of sterile medicinal products which are designed to replace reusable equipment. SUS are typically defined systems made up of components such as ...

May 14, 2020

By Particle Measuring Systems

Control Microbes with Monitoring of your Cleanroom

Microbial Environmental Monitoring To achieve compliance to regulatory guidance, a microbial monitoring program includes the following components: Active air (room or enclosure environment) Passive air (settle plates) Surfaces (contact plates and swabs) Personnel (gloves and garments) Compressed gases Materials and equipment that could compromise product microbiological quality Cleaning ...

May 29, 2019

By Particle Measuring Systems

Potential Cleanroom Sampling Points per Annex 1 Draft

In part 4 of our part 5 blog series on Annex 1 Quality Risk Management, we discuss cleanroom sampling points. Definition of potential sampling points Sample points include particle counters and microbial monitors. Identification of critical areas by HACCP analysis and process understanding Choose points within the critical areas according to defined criteria When performed this way, you ...

Apr. 30, 2020

By Particle Measuring Systems

Table of Statistical Corrections According to Feller for the BioCapt® Microbial Impactor in Microbial Air Sampling

What are the newest Annex 1 Single use Requirements and does the BioCapt Single use Impactor meet them?

Control Microbes with Monitoring of your Cleanroom

Potential Cleanroom Sampling Points per Annex 1 Draft

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