Tag Archives: standards

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Contamination Control

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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 →

Review of Draft Standard: AS 2828.2 Health records, Part 2: Digitized health records

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One way I keep myself up to date with developments within laboratories and related areas is by reviewing draft standards.  This keeps me appraised of the current state of affairs, keeps my documentation audit skills fresh and potentially allows me to contribute to the content of standards.  For this draft standard, I have some knowledge of IT and IT security so am able to critically review the draft standard and offer comment.

Notes: refer to the conditions for comment stated towards the beginning of the draft standard.

DR AS 2828.2 Health records, Part 2: Digitized health records Continue reading →

Review of Draft Standard: AS 2243.2 Safety In Laboratories – Part 2: Chemical Aspects

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One way I keep myself up to date with developments within laboratories and related areas is by reviewing draft standards.  This keeps me appraised of the current state of affairs, keeps my documentation audit skills fresh and potentially allows me to contribute to the content of standards.

Notes: refer to the conditions for comment stated towards the beginning of the draft standard.

Update 20190103: After proceeding to submit comments, I observed page numbers were required.  That is important to note for future reviews.  Page numbers added.

DR AS 2243.1 Safety In Laboratories – Part 2: Chemical Aspects Continue reading →

Review of Draft Standard: AS 2243.1 Safety In Laboratories – Planning and Operational Aspects

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One way I keep myself up to date with developments within laboratories and related areas is by reviewing draft standards.  This keeps me appraised of the current state of affairs, keeps my documentation audit skills fresh and potentially allows me to contribute to the content of standards.

Here I step through the draft standard making comments.  Where a comment is answered later in the standard, I go back to my original comment and make notes.  An uncommented comment is potentially worthy of becoming an official comment on the standard.

Update 20190103: page nubmers added.

Section 1 Continue reading →

Notes on ISO 13408-2 (2003) – Aseptic processing of health care products – Part 2 : Filtration

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I found the latest ISO online here.  As far as I can tell it is legit (in so far as allowing the ISO online for free) – it certainly is the current ISO.

A recent HR rep from a pharmaceutical company contacted me regarding an open role I Sydney.  After passing my details along to “senior management”, the response I got was “We have had some discussion with senior quality managers about your profile and unfortunately they feel your relevant experience in Sterile Micro going back 10 years is a little too long for us ideally”.

Such a response show a lack of foresight from the employer as they do not want the best candidate for the job.  Do they want someone who knows their stuff?  No.  Do they have a commitment to training and staff development?  No. Continue reading →

Notes on International Standard ISO 13408-1: 2008

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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 →

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

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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 →