Saturday 30 June 2018

Pharmig publications

Factsheets cleanroom isolates

Standard microbiology text books are biased to medical bacteria. These factsheets provide pharmaceutical microbiologists with details on the most common isolates from pharmaceutical cleanrooms.

The factsheets provide descriptive information and characteristics of the main organisms, to help microbiologists tasked with investigations, together with full colour colony and growth characteristics, and typical Gram-stain profiles, to assist those who carry out identifications.

These laminated sheets are ideal for use on the laboratory bench, to assist microbiologists as they carry out their work, and as handy training aids.

Factsheets on fungi

Regulators have stated that knowledge of fungal identification is weak in microbiology laboratories, and many inspectors expect fungi to be identified as part of microbial contamination tracking. The problem is, few text books focus on the most common cleanroom isolates.

Pharmig has addressed a gap by profiling the most common fungi found in cleanrooms (based on FDA recalls) and presenting full colour guides to the cultivation and identification of these fungi.  Included with the macroscopic and microscopic images is detailed advice on where these fungi are found and what the implications for their recovery means.

These laminated sheets are ideal for use on the laboratory bench, to assist microbiologists as they carry out their work, and as handy training aids.

Rapid and alternative methods

Most microbiologists are seeking to invest in and develop rapid or alternative microbiological methods, in order to produce more accurate and faster results. There are also advantages in terms of automation and data integrity.

Finding out about the different technologies and then selecting between methods can be challenging. This publication provides an overview of different types of technologies and profiles many of the current methods available.

The guide also provides microbiologists (and their management chain) with guidance on selecting and qualifying methods (running the IQ, OQ and PQ spectrum). Also included is detail on how to build a case for justifying a method, considering factors like return on investment.

Factsheets on objectionable organisms

Objectionable organisms is a buzz phrase in the pharmaceutical sector, prompted by a push from regulators to consider those microorganisms beyond those described in the pharmacopeia as specified organisms that might pose a risk to products.

This series of factsheets describes the criteria for determining whether an organism is objectional or not (looking at things like product risk profiles and the patient population), and presents profiles of many common objectionales. These organisms have been selected based on their commonality to the environment and appearance in recall observations from inspectors.

The fact sheets use colour photographs illustrating growth on agar and by Gram-stain. These are supported by facts relating to the organism’s profile and methods for identification.

The sheets are presented in a pack and together provide a unique, informative and colourful guide to an important area of quality control microbiology.

Factsheets on Microbial Limits Test organisms

The Microbial Limits Test is the mainstay of many pharmaceutical microbiology laboratories. While the test is common there are challenges, such as identifying and characterising the specific microorganisms described in the pharmacopeia.

These factsheets are designed to act as a training aid for new staff, and an aide memoire for more experienced staff. The sheets use colour photographs to illustrate growth on agar and by Gram-stain. Each organism is additionally profiled, with information relating to the organism’s profile and risks to the patient.

The sheets are laminated and presented in a pack and together provide a unique, informative and colourful guide to an important area of quality control microbiology.

Best Practices in Microbiological Documentation – Electronic Pack One

Microbiology laboratories contain many computerised systems, SOPs, protocols and forms. When setting up a microbiology laboratory, generating the required documentation is a huge task. This Pharmig pack provides all of the necessary templates you’ll need in a downloadable and editable format.

The pack includes:

·         Training in setting up electronic systems.
·         Advice on electronic systems.
·         Templates for laboratory SOPs and protocols.
·         Examples of test forms for a range of common QC microbiology tests.
·         The full range of validation documentation for laboratory equipment, from URS to IQ, OQ, and PQ files.

The various files will also be of interest to the established laboratory manager, serving as a useful best practice benchmark.

Setting up and Managing an Effective Training Programme in the Micro Laboratory – Electronic Pack Two

In every regulatory inspection training features and the training folder of the microbiologist is certain to be inspected. Are you using the most appropriate format for your training? This pack provides an array of templates for the full range of QC microbiology tests.

Just as important as training is assessment. But how to assess? What should be practically demonstrated? Which questions to ask of the trainee? This pack provides a range of downloadable and fully editable assessments for everything from microbial identifications to environmental monitoring.

Also included are templates to allow laboratory managers to track, trace and trend training. By purchasing this pack, the managers and the microbiology team will be audit ready.

LAL factsheets

Endotoxin testing is an important area for many microbiology laboratories. Training in the LAL test is often best broken down into bite-sized chunks, and these factsheets provide single-point lessons on the key aspects of the test.

Areas covered include:

·         What is LAL/BET?
·         Calculation of endotoxin limits
·         Medical devices
·         Gel clot methods
·         Photometric methods
·         Product validation quantitative methods

These areas are explained in clear and concise language, together with practical examples and with illustration.

The sheets are presented in a pack and they are laminated, making them an ideal bench-side training aid.

Best practices for the Bacterial Endotoxin Test: A Guide to the LAL Assay

The core parts of the LAL test for endotoxin is described in the main pharmacopeia, but there are many things left out and others that are less clear, especially when training new staff.

This comprehensive guide describes how to:

·         How to undertake method development.
·         How to validate new samples.
·         Explains concepts like maximum Valid Dilution and Endotoxin Limits.
·         Outlines how to run a depyrogenation study.
·         Looks at medical device testing.
·         Contains a detailed trouble shooting guide.

This book provides a useful reference document for LAL users.

Current perspectives on Environmental Monitoring

All microbiologists need to carry out environmental monitoring, whether this is of a major plant or within the laboratory safety cabinet. Many aspects of monitoring are not well described and this Pharmig book addresses this.

The book contains chapters written by industry experts, covering:

·         How to set up an environmental monitoring programme.
·         Cleanroom microbiology.
·         How to evaluate environmental monitoring methods.
·         How to clean and disinfect effectively.
·         Tips for achieving particulate control.
·         How to run a risk assessment following an adverse trend.

Whether a beginner or an advanced practitioner, this guide has something for pharmaceutical microbiologists and their management teams.

Microbiological Control for Non-Sterile Pharmaceuticals

There is far more guidance for sterile manufacturers than those involved with non-steriles in relation to microbial contamination risks and control measures. To address this gap, Pharmig has produced this guide for microbiologists working in this field.

The guide covers:

·         Best facility design requirements.
·         Microbial risks in non-sterile manufacturing.

·         Best practice tips for achieving microbial control.
·         How to clean and disinfect effectively.
·         Advice on undertaking risk assessments.
·         Microbiological testing.
·         Environmental monitoring.

The guide helps steer the microbiologists through the regulatory expectations, offering many practical examples.

Guide to Cleanroom Operation and Contamination Control

Cleanrooms are the fabric within which most pharmaceutical processing takes place, yet not all pharmaceutical microbiologist are familiar with how they work and the contribution they make to minimising contamination.

In addition there are several different cleanroom standards and making sense of these and drawing comparisons can be changing. 

This Pharmig guide:

·         Describes the contamination control features of cleanrooms.
·         Explain the different cleanroom standards and how they compare.
·         Provides detail of the recently updated ISO 14644 standard (Parts 1 and 2).
·         Descries the different test methods for cleanrooms, like particle classification; pressure monitoring; air change rates and so on.

The guide is useful for microbiologists and cleanroom managers – helping to link engineering principles for microbiologists.


Posted by Dr. Tim Sandle

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