Notes on International Standard ISO 13408-1: 2008

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

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Microbiology For Non Microbiolgists

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)
  • Number of attendees: 5-10

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Viable Environmental Monitoring

What Is Viable Environmental Monitoring (VEM)?

Viable environmental monitoring 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, surfaces (as in introduced equipment), liquids, people.

Why Is VEM Needed?

Microbial monitoring is used to determine if the controlled environmental being monitored is within an adequate state of microbiological control (i.e whether or not the area meets the specifications as described in the site quality manual, product registration dossiers and associated documents) . It may also be used to confirm that cleaning and sanitation is effective (and being conducted as specified) and that personnel within the production environment are not carrying an unacceptable bioload or inadvertently causing contamination. This is required information as it ensures that products produced are unadulterated and are fit for their intended purpose. Continue reading

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

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>

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