Tag Archives: sterile

post

Contamination Control

Posted on by

Having worked in sterile production environments where contamination control was vital, there were zero exceptions to following the established procedures. Exceptions would invariably lead to unacceptable outcomes. With regards to lock-down and quarantine in relation to SARS-COV-2, there are many exceptions and deviations from the requirements. That will only lead to….you guessed it, an unacceptable outcome.  With this in mind, I present to you a brief article on contamination control in sterile production environments. Continue reading →

Questions About What To Do With Lids When Air Sampling

Posted on by

The Question posed directly:

“Hi. I have a cleanroom question. When collecting an air sample with an air sampler device can you put the impactor head down when changing the plate.  Can you put the lid of the plate down when you change the plate.  What do you do with the two lids when changing the plate as I thought you could not put them down.

Thanks“

Continue reading →

post

Comparison of PIC/S PE009-13 and PE009-14

Posted on by

Introduction

The PIC/S Guide to Good Manufacturing Practice PE009-13 was published January 1, 2017.  Edition 14 was published on 1 July, 2018.

The TGA adopted version 13 of the guide in 2018 and “just given” notice that it intends to adopt the current version of the PIC/S Guide (PE009-14) by July 1st 2020.

So you know what changes, if any you need to make to be in compliance with PE009-14, what are the key differences between these two guidance documents? Continue reading →

Notes on International Standard ISO 13408-1: 2008

Posted on by

One of the main International Standards used as a reference document in a sterile pharmaceutical microbiology laboratory is ISO13408 – Aseptic Processing of Health Care Products .  Long ago, I reviewed the 1998 edition.  More recently, I acquired ISO 13208-1 (2008), so I compared my notes from the 1988 version with what is stated in the 2008 version.  The use of italics is my way of emphasising points.  Notes on changes are in blue.

INTRODUCTION

When I reviewed the 1998 edition, I did not note down any of the introduction.

  • Anything labelled as sterile needs to made under tight control as part of a Quality Management System
  • This part of the ISO focusses on the risks to the maintenance of sterility
  • All possible sources of contamination need to be controlled and a risk based approach is recommended
  • Appropriate validation of the aseptic process is needed and process simulation trials are an essential part of this

Continue reading →

post

Microbiology For Non Microbiolgists

Posted on by

I have experience developing training and presenting it to small to medium sized groups. Part of this process involves determining the way in which to present the training. Once such way to use some form of visuals in support of speaking. For my Microbiology for Non Microbiologists course, I used Microsoft Powerpoint.

Duration of Session:

  • 60 minutes x1, followed by 10 minutes x1 (display style).  Include practical component.
  • Number of attendees: 5-10.  Can be presented to up to 30.

Continue reading →

Viable Environmental Monitoring

Posted on by

This was repurposed into a LinkedIn article as part of my Developing My Writing While Helping Others series.

What Is Viable Environmental Monitoring (VEM)?

Viable Environmental Monitoring (VEM) is the monitoring of factors within a production environment that may have an impact on the quality of goods produced within the environment. Typically this is any physical object than could support or introduce microbial contamination to a manufacturing environment: air, gases, surfaces (both on introduced objects and within the production room), liquids and people.  This discussion does not extend to Environmental Monitoring such as particle counting, temperature, pressure differentials, etc. Continue reading →

Notes on International Standard ISO 13408-1: 1998(E)

Posted on by

One of the main International Standards used as a reference document in a sterile pharmaceutical microbiology laboratory is ISO13408 – Aseptic Processing of Health Care Products .  Long ago, I reviewed the 1998 edition.  The 2008 edition of the standard was last reviewed and confirmed in 2011 as current.  Part 1 details the general requirements.  The 2008 edition is edition 2 and is a techncial revision of the 1998 document.  The guts of the standard are not dissimilar to version 1.

My review of the 1998 edition follows.  When I get my hands on the 2008 edition, I’ll review that with reference to this review.

The use of italics is my way of emphasising points. Continue reading →

Notes on USP31-NF26 <1116 - Microbiological Evaluation of Cleanrooms and Other Controlled Environments>

Posted on by

Modified 20181212 – minor typos corrected. minor updates.

The USP is the United State’s Pharmacopeia.  If you are selling pharmaceuticals in the USA, you need to follow the USP and are subject to FDA regulation.  For the layperson, a pharmacopeia is an official publication containing a list of medicinal drugs with their effects and directions for their manufacturing, testing and use.

I last reviewed USP 1116 in 2009 when it was version USP31–NF26.

Where one does not have direct access to the USP (it is behind a pay wall),  there are plenty of sites that review changes and publish their considered opinions.  The USP itself publishes Revision Bulletins, IRA’s (public comment documents showing proposed changes) and Errata.  From these one can build up a fairly accurate picture of the USP.

The latest iteration is USP 41–NF 36 — this became official on May 1, 2018.  The last version I managed to get my hands on was USP36 NF31.  What follows is my original review. Continue reading →