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.
See:
https://www.pharmig.org.uk/en/product/a-series-of-8-fact-sheets-on-major-objectionable-organisms/
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.
See:
https://www.pharmig.org.uk/en/product/current-perspectives-on-environmental-monitoring-review-1/
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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Pharmaceutical Microbiology Resources