Saturday, 31 October 2015

Food Safety in Manufacturing


New FDA Rules Focus on Food Safety in Manufacturing: Food manufacturers are facing an update to equipment and facility designs to comply with the newest U.S. Food & Drug Administration’s (FDA) safety rules, which focus on the prevention of foodborne illness.

In reaction to a string of recent outbreaks of listeria and salmonella, the FDA announced it has finalized the first two of seven major rules under the Food Safety Modernization Act (FSMA), which focus on implementing modern food manufacturing processes for both human and animal foods that are produced domestically or are imported. Food manufacturers are facing an update to equipment and facility designs to comply with the newest U.S. Food & Drug Administration’s (FDA) safety rules, which focus on the prevention of foodborne illness. In reaction to a string of recent outbreaks of listeria and salmonella, the FDA announced it has finalized the first two of seven major rules under the Food Safety Modernization Act (FSMA), which focus on implementing modern food manufacturing processes for both human and animal foods that are produced domestically or are imported.



 Posted by Tim Sandle

Friday, 30 October 2015

New ISO Cleanroom Classification and Monitoring Standards


ISO 14644 Parts 1 and 2 have finally been approved!

Official notice from the IEST:

The Institute of Environmental Sciences and Technology (IEST) announces the international approval of the new revisions to the cornerstone cleanroom standards—ISO 14644, Cleanrooms and associated controlled environments, Part 1: Classification of air cleanliness by particle concentration and Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration. IEST serves as the Secretariat organization for ANSI for ISO Technical Committee 209 (ISO/TC 209), which is responsible for the cleanroom standards’ development.

The revised 14644-1 and -2 Standards were approved by a significant majority of the 20 member nations participating in the ISO/TC 209 final vote. The International Standards will be available from IEST following editorial revision and international translation. ISO’s recent measures to bring standards to industry more quickly is expected to lead to published versions within a period of weeks. Cleanroom industry customers and suppliers are encouraged to check www.iest.org for updates on availability of the International Standards. IEST is offering several course options to educate stakeholders regarding the requirements and use of the new revisions.

ISO 14644-1 and -2 are so critical to the estimated $14 billion cleanroom industry that the revision efforts by the lead ISO/TC 209 Working Group lasted more ten years, with the ISO Technical Management Board providing a perhaps unprecedented second extension of the drafting period. The Standards are part of a concurrent adoption as American National Standards, which would take effect in tandem with the international publication.

ISO 14644-1 specifies classes of air cleanliness for the world’s cleanrooms and controlled environments in terms of the number of particles expressed as a concentration in air volume. To determine the class, a specified testing method is required, which includes selection of sampling locations. A major focus in revising ISO 14644-1 (1999) was development of a refined statistical approach regarding the selection and number of sampling locations. The underlying assumption in the 1999 version held that particle counts follow a similar distribution across the room. The new revision discards the previous assumption in order to allow more accurate sampling where particle counts may vary in a more complex pattern.

Another revision in ISO 14644-1 addresses the issues surrounding ≥ 5 μm particle limits for ISO Class 5 in the sterile products annexes of the EU, PIC/S, and WHO GMPs. An adaptation of the macroparticle descriptor is included in the Standard to accommodate the particle size.

ISO 14644-2 emphasizes the need to consider a monitoring strategy in addition to the execution or evaluation of the classification provisions of ISO 14644-1. The requirements of a monitoring plan are detailed, including additional guidance on risk assessment as part of an informative annex.

The mission of ISO/TC 209 is to develop international standards for cleanrooms and associated controlled environments encompassing standardization of equipment, facilities, and operational methods. The committee defines procedural and operational limits and testing procedures to achieve desired attributes to minimize contamination. IEST serves as the Secretariat for ISO/TC 209 and is also the Administrator for the United States Technical Advisory Group (US TAG) to ISO/TC 209. ISO Standards and IEST Recommended Practices for cleanrooms and controlled environments are available through IEST at www.iest.org.

Posted by Tim Sandle

Biopharma Operational Excellence


Pharmaceutical Manufacturing has issued an e-book on “Biopharma Operational Excellence”.

Operationally, biopharmaceutical manufacturing is challenging and complex. Fortunately, process innovation and new upstream and downstream technologies are allowing drug makers to take formulations from development to commercial scale faster and more cost-efficiently.

The articles that follow offer information and practical advice on navigating the biopharma space to deliver more successful operations and safer drugs:
  • Time for a New Prescription
  • Critical Trends Driving Biomanufacturing Production Strategies
  • Applying Single-Use Efficiences to Room-to-Room Fluid Transfer
  • Value Delivery's Next Chapter
  • Where is Biopharma in the PAT Picture?

For details see: Pharma Manufct

Posted by Tim Sandle

Thursday, 29 October 2015

ISO 14644 Parts 1 and 2 approved



Via a tweet, IEST announces that the revised ISO 14644-1 and -2 cornerstone cleanroom standards have been approved as International Standards.


ISO 14644-1, the first document in the 14644 series, was published in 1999, and ISO 14644-2 was published the following year. The documents have been subject to revision for several years. ISO 14644-1 specifies classes of air cleanliness for the world’s cleanrooms and controlled environments in terms of the number of particles expressed as a concentration in air volume. To determine the class, a specified testing method is required, which includes selection of sampling locations.

ISO 14644-2 emphasizes the need to consider a monitoring strategy in addition to the execution or evaluation of the classification provisions of ISO 14644-1.

Revisions of ISO 14644-1 and -2 were released In December 2010 as Draft International Standards. Four years later, a second round of revisions to ISO 14644-1 and -2 was released as Draft International Standards. These revisions provided a clearer classification of air cleanliness in cleanrooms and associated controlled environments exclusively in terms of concentration of airborne particles of a designed size range. Final Draft International Standards of both documents were released in August 2015.

The improved sampling method in the revised ISO 14644-1 document along with the enhanced guidance for particle counter calibration and performance will provide improved confidence to cleanroom users that their cleanroom is delivering the preferred level of quality-controlled environment for critical life science applications.



Posted by Tim Sandle

Sulfolobus


Sulfolobus is part of the Archaea kingdom -- a single-cell organism similar to bacteria -- which was isolated in hot springs on the island of Hokkaido, Japan.

Some Archaea live ordinary lives in mundane environments such as lakes, seas and insect and mammal intestinal tracts, while others live extraordinary lives pushed to extremes in incredibly harsh habitats such as deep sea hydrothermal vents, volcanic mud and the Dead Sea.

Archaea have been instrumental in evolutionary studies on the origins of life and have revealed to scientists that the boundaries of life as we know it can be pushed much further than previously thought.

For details about the organisms:

M. A. Schumacher, N. K. Tonthat, J. Lee, F. A. Rodriguez-Castaneda, N. B. Chinnam, A. K. Kalliomaa-Sanford, I. W. Ng, M. T. Barge, P. L. R. Shaw, D. Barilla. Structures of archaeal DNA segregation machinery reveal bacterial and eukaryotic linkages. Science, 2015; 349 (6252): 1120 DOI: 10.1126/science.aaa9046



Posted by Tim Sandle

Wednesday, 28 October 2015

Endotoxin Assay Selection Guide


A new review has been undertaken by Lonza:

“Users can choose between qualitative vs. quantitative assays, assays that rely on gel formation or color development, as well as kinetic and endpoint assays. For someone new to endotoxin testing, selecting an appropriate method may not be easy.”

To access, see Lonza


Posted by Tim Sandle

Tuesday, 27 October 2015

Dr. Scott V.W. Sutton Memorial Fund

A note from the late Dr. Sutton’s family:

“Scott V.W. Sutton passed away suddenly on the nineteenth of October in 2015. He was a loving father and husband, a respected expert in microbiology, and a devoted friend.

The shockwaves of his passing can be felt throughout each of the many communities in which Scott was involved. Everyone who's known Dr. Sutton has known him first and foremost as a loyal friend, and they've reached out to his family hoping to have a way to contribute to his memorial.

For those effected by his loss and interested in helping his family, we've set up this memorial fund.”

For details see: Scott V.W. Sutton Memorial Fund

Posted by Tim Sandle

Settle plate exposure under unidirectional airflow - how to evaluate explained



Settle plates play an important part in the environmental monitoring programme and for the assessment of microbial settlement at key locations within cleanrooms, particularly when situated within unidirectional airflow devices. It is important that the exposure time of the settle plate is assessed to ensure that the proportion of weight loss (through the loss of moisture) does not result in a loss of growth-promoting properties. A second important concern is with avoiding cracks in the agar which might render reading sections of the exposed plate impossible. This paper outlines a case study to assess the exposure time through microbial growth promotion.

In relation to this key aspect of environmental monitoring, Tim Sandle has written a paper which has been published in the European Journal of Parenteral & Pharmaceutical Sciences.


The reference is:

Sandle, T. (2015) Settle plate exposure under unidirectional airflow and the effect of weight loss upon microbial growth, European Journal of Parenteral & Pharmaceutical Sciences 2015; 20(2): XX

To view a copy, please contact Tim Sandle

Posted by Tim Sandle

Monday, 26 October 2015

Incidences and Treatments for Buruli Ulcer



Buruli ulcer is a bacterial disease, alternatively called Bairnsdale ulcer, Searls ulcer, or Daintree ulcer. The tropical disease causes blood clots on the skin and, when untreated, leads to severe ulceration. The infectious disease caused by a bacterium called Mycobacterium ulcerans. It is the third most common mycobacterial disease after tuberculosis and leprosy.

The current treatment option primarily involves courses of antibiotics. More serious or untreatable cases require surgical intervention. To improve current treatment regimes, scientists are investigating alternative approaches; this article assesses some of these approaches alongside current practices.

In a short article, Tim Sandle assesses the current strategies and new treatment options for the disease.

The reference is:

Sandle, T. (2015) Incidences and Treatments for Buruli Ulcer, Journal of Ancient Diseases &
Preventive Remedies, 3 (2): 1000e122 (http://dx.doi.org/10.4172/2329-8731.1000e122)

For further information or to review a copy please contact Tim Sandle



 Posted by Tim Sandle

Sunday, 25 October 2015

Advancing Biopharma Analysis with Light-Scattering Detection

An e-book of interest has been issued:

To characterize biopharmaceuticals, particularly monoclonal antibodies and antibody-drug conjugates (ADCs), you need a complete toolbox of powerful tools.

The key points:
  • How light scattering works
  • Current uses of light-scattering, such as:
  • Determining absolute molecular weight
  • Studying PEGylated proteins
  • Characterizing antibody-drug conjugates
  • Studying protein aggregation
  • When to use light-scattering detection, and when to use mass spectrometry
  • Why you should consider light-scattering to determine the drug-antibody ratio of antibody-drug conjugates, and for effective characterization of the chemical, thermal, and colloidal stability of ADCs
To view the book, go to: Chromatography Online

Posted by Tim Sandle

Saturday, 24 October 2015

Modular Cleanroom Systems


The benefits of modular cleanroom systems have remained relatively consistent over the years. They feature a quick and clean installation process, consistent product quality, reduced construction time, certain tax advantages, and “green” benefits resulting from a reduced material waste.

Wayne McGee has written an interesting article on the subject for Controlled Environments magazine. An extract reads:

The main types of modular cleanrooms are:

Softwall cleanroom systems - Softwall cleanrooms provide an economical solution to applications requiring light environmental control.

Structural post and panel systems - The core product for many modular manufacturers and suppliers consists of an “all-purpose” system that can be utilized for a variety of applications from GMP rooms to specific ISO classes.

Framing/partitioning systems - Due to the critical environmental conditions that are demanded in precision microelectronics manufacturing and nanotechnology applications, cleanrooms in these industries have typically required systems that integrated well with the equipment needed to run these operations.

Aseptic systems - Due to the unique needs and requirements found within the biomedical, life science, medical device, and pharmaceutical industries, modular cleanroom manufacturers have developed systems exclusively for these markets.

To access the article, see Controlled Environments.

Posted by Tim Sandle

10th Parenteral Drug Association (PDA) pharmaceutical microbiology conference report

Near Washington D.C., pharmaceutical microbiologists recently gathered to discuss drug safety concerns together with the latest technologies. Here we report from the 10th Parenteral Drug Association (PDA) pharmaceutical microbiology conference.


The PDA Global Microbiology Conference is the largest gathering of microbiologists, together with other scientific disciplines, engineers and quality personnel, related to pharmaceuticals and healthcare products in the world. This year the conference took place at the Bethesda North Marriott Hotel and Conference Center. The vent was aimed at industry, academic, and regulatory professionals.
Bethesda North Marriott Hotel and Conference Center; a view of the hotel exterior.
Bethesda North Marriott Hotel and Conference Center; a view of the hotel exterior.
The conference spans three days, often with two streams running concurrently together with plenary sessions. Days begin at 7 a.m. with work groups and run onto 6 p.m., resulting in plenty of discussion, debate and activity. The conference program was put together by a PDA organizing committee and co-chaired by Amy McDaniel, PhD of Pfizer, Inc. and Kalavati Suvarna, PhD, of the U.S. FDA.
Day one of the conference opened with two key note speakers on Ebola. The first was from Michael Kurilla, MD, Director, Office of BioDefense Research Affairs, National Institute of Allergy and Infectious Diseases (NIAID), which is part of the U.S. National Institutes of Health (NIH) and Luciana Borio, MD, Assistant Commissioner, Counterterrorism Policy and Acting Deputy Chief Scientist, Office of Counterterrorism and Emerging Threats at the U.S. Food and Drug Administration (FDA.)
Dr. Kurilla presented on the reasons why the current Ebola crisis in West Africa has been so devastating. This related to infrastructure, controls, customs, and new information about the undiscoverability of the virus itself. Digital Journal carries a full review of Dr. Kurilla's presentation here.
Dr. Borio explained the FDA's role in the Ebola situation, especially in relation to the safety assessment and approval of new drugs. Here Dr. Borio explained why the process of assessment is sometimes seen as slow, which she puts down to the importance of safety assessments. Here she drew a contrast with European authorities who have been more willing to release Ebola drugs with less efficacy data. Digital Journal has an in-depth review of Dr. Borio's presentation here.
Following these presentations the conference divided into different streams. One was chaired by Michael Miller, PhD, President, Microbiology Consultants, LLC. This focused on rapid microbiological methods, a subject for which Dr. Miller is one of the world's leading authorities. These are methods designed either to give a faster time-to-result, so that medicines can be released faster in relation to an assessment about microbiological contamination, or where methods are more accurate.
Program for the PDA 10th Annual Global Conference on Pharmaceutical Microbiology  where Ebola resear...
Program for the PDA 10th Annual Global Conference on Pharmaceutical Microbiology, where Ebola research was featured.
The second stream looked at microbial contamination control case studies. This was chaired by Marsha Stabler Hardiman, Senior Consultant at ValSource, LLC. This session included a presentation delivered by Jeanne Moldenhauer, who is Vice President at Excellent Pharma Consulting, Inc. Jeanne spoke about how microbiologists need to focus on preventing contamination incidences from occurring rather than continually gearing themselves up to investigate incidents when they occur. To do this, she emphasized, required a new paradigm.
The first stream of the afternoon was chaired by Dr. Amy McDaniel, looking at innovative technologies. Running in parallel Dr. Kalavati Suvarna chaired a session on risk assessment. This contained a good presentation by Jim Polarine on strategies for fungal contamination.
These sessions led into a plenary session chaired by Dr. Richard Levy on myths relating to microbiology. The three speakers were Dr. David Hussong, who covered common misinterpretations about pharmaceutical drug manufacturing; Dr. Tim Sandle, who addressed common laboratory myths; and Captain Sharon Thoma, who looked at inspections by regulatory authorities.
Access all areas - Tim Sandle s PDA conference badge
Access all areas - Tim Sandle's PDA conference badge
The key note speaker on day two was delivered by Andrew Gewirtz, PhD, Professor, Center for Inflammation Immunity and Infection, Georgia State University. Dr. Gewirtz raised some interesting issues pertaining to processed foods and the effect they have gut microorganisms and a potential role in disease. These issues are explored further in an in-depth Digital Journal feature.

Parenteral Drug Association logo. The PDA was founded in 1946 and it a non-profit making science soc...
Parenteral Drug Association logo. The PDA was founded in 1946 and it a non-profit making science society.
The conference then divided into two streams. One was led by senior FDA reviewer Dr. Vinayak Pawar, on biofilms and endotoxin, with a strong focus on how water systems become contaminated and how contamination can be addressed. The second was moderated by Osama (Sam) Elrashidy, looking at quality issues. This stream included an important presentation by Dennis Guilfoyle, PhD, Senior Director, Microbiology and Analytical Regulatory Compliance, Johnson & Johnson, about the quality issues surrounding several compounding pharmacies and the spate of recalls over the past three years.
Two further streams followed. One was on biotechnology, moderated by Kim Sobien; the second looked at how regulatory agencies and pharmacopeia bodies can work more closely together, led by Julie Barlasov.
Delegates in between sessions at the PDA 10th Annual Global Conference on Pharmaceutical Microbiolog...
Delegates in between sessions at the PDA 10th Annual Global Conference on Pharmaceutical Microbiology.
The final plenary of the day allowed younger scientists the opportunity to present their thoughts and research in a series of fifteen minute presentations. Many of these were extremely good. The presenters were: Jarett Scalzo, QC Microbiologist Supervisor, Agensys, Inc. (on risk assessment); Ayako Hasegawa, PhD, Senior Scientist Applied Microbiology, Allergan, Inc. (on aseptic processing); Susan Hatley, Scientist I, Pfizer, Inc. (on processing contamination) and Lia Jeffrey, PhD, Senior Manager, Genentech, Inc. (on developing a laboratory test method for anaerobic bacteria.)
During a gala dinner later that evening, a life time achievement award was presented to Dr. Tony Cundell. Among his many achievements, Dr. Cundell is currently co-chair of the PDA task force on the exclusion of objectionable microorganisms from pharmaceutical drug products, medical devices, consumer health products and cosmetics.
Dr. Tony Cundell receiving the distinguished service award from the PDA.
Dr. Tony Cundell receiving the distinguished service award from the PDA.
Day three had a regulatory focus. Dr. David Hussong discussed developments and future work for the United States Pharmacopeia and Karen McCullough discussed endotoxin. These were followed by a review of the recent FDA re-organization delivered by Lynne Ensor.
The final feature of the conference was a two hour "ask the experts" panel where international experts in pharmaceutical microbiology fielded questions from the audience. The panel included Dr. Lynne Ensor; Dr. Tim Sandle; Captain Sharon Thoma; and Dr. Patricia Hughes.
A pillar listing the organizing committee of the 10th annual PDA microbiology conference.
A pillar listing the organizing committee of the 10th annual PDA microbiology conference.
What is especially good about the conference is the opportunity to meet and mingle with the U.S. Food and Drug Association (FDA), where reviewers and inspectors are present along with senior staff. There is no other conference that I am aware of where the so-called 'regulatory divide' is temporarily suspended.
There was a sad note at the conference with the passing away of Dr. Scott Sutton. Scott was one of the pioneers of 'modern' pharmaceutical microbiology and he had been instrumental in the development of techniques relating to antimicrobial effectiveness testing and with the neutralization of disinfectants (something necessary to avoid 'false negatives' and to enhance the accuracy of microbial counts.) I had spoken with Scott on the afternoon of Sunday 18 October and exchanged pleasantries. Later it was announced that he died later in the evening in his hotel room. He was an inspirational figure to me, as a microbiologist, and I would frequently reference his writings. I hope that some future award or conference theme is named in his honor.

Posted by Tim Sandle

Friday, 23 October 2015

Competency Guidelines for Public Health Laboratory Professionals



The U.S. Centers for Disease Control and Prevention has recently issued a guidance document titled “Competency Guidelines for Public Health Laboratory Professionals: CDC and the Association of Public Health Laboratories.”

The summary reads:

“These competency guidelines outline the knowledge, skills, and abilities necessary for public health laboratory (PHL) professionals to deliver the core services of PHLs efficiently and effectively.

As part of a 2-year workforce project sponsored in 2012 by CDC and the Association of Public Health Laboratories (APHL), competencies for 15 domain areas were developed by experts representing state and local PHLs, clinical laboratories, academic institutions, laboratory professional organizations, CDC, and APHL. The competencies were developed and reviewed by approximately 170 subject matter experts with diverse backgrounds and experiences in laboratory science and public health. The guidelines comprise general, cross-cutting, and specialized domain areas and are divided into four levels of proficiency: beginner, competent, proficient, and expert.

The 15 domain areas are 1) Quality Management System, 2) Ethics, 3) Management and Leadership, 4) Communication, 5) Security, 6) Emergency Management and Response, 7) Workforce Training, 8) General Laboratory Practice, 9) Safety, 10) Surveillance, 11) Informatics, 12) Microbiology, 13) Chemistry, 14) Bioinformatics, and 15) Research.

These competency guidelines are targeted to scientists working in PHLs, defined as governmental public health, environmental, and agricultural laboratories that provide analytic biological and/or chemical testing and testing-related services that protect human populations against infectious diseases, foodborne and waterborne diseases, environmental hazards, treatable hereditary disorders, and natural and human-made public health emergencies.”

The document can be found here: CDC.

Posted by Tim Sandle

Thursday, 22 October 2015

Revision of PIC/S GMP Guide



The PIC/S GMP Guide (PE 009-12) has been revised to incorporate revised Annex 15. It will entered into force on 1st October 2015.

The guide states:

“In order to further facilitate the removal of barriers to trade in medicinal products, to promote uniformity in licensing decisions and to ensure the maintaining of high standards of quality assurance in the development, manufacture and control of medicinal products, the following Guide to Good Manufacturing Practice for Medicinal Products and its Annexes has been adopted.

The standards set out herein apply to medicines and similar products intended for human use. It is recommended, however, that the same kind of attention be given to the manufacture of veterinary products. Administrative measures of national health authorities should be directed towards the application of these standards in practice, and any new or amended national regulations for good manufacturing practice should at least meet their level. These standards are also intended to serve manufacturers as a basis for the elaboration of specific rules adapted to their individual needs.”

For details see PIC/S



 Posted by Tim Sandle

Wednesday, 21 October 2015

Cell Therapy Catapult of regulatory requirements


U.K. MHRA advises the Cell Therapy Catapult of regulatory requirements:

In 2012, the Cell Therapy Catapult was established by Innovate UK as a centre of excellence for innovation, with a view to developing a world-leading cell and gene therapy industry in the UK. Their mission is to drive the growth of the industry by helping cell and gene therapy organisations around the world to translate their early-stage research into commercially viable therapies.

One exciting new development is the advent of induced pluripotent stem cells (iPS) for use in new therapeutic products. iPS cells are developed by taking specialised adult dividing cells (e.g. skin cells) and ‘reprogramming’ them back to stem cells. These stem cells are considered to be ‘pluripotent’, meaning that they can be used to make any type of cell in the body.

In late 2013, the Cell Therapy Catapult partnered with Roslin Cells to establish a source of clinical grade iPS cells banked according to good manufacturing practice (GMP) in the UK, which can be used to accelerate the growth of the industry, specifically the progression of iPS based therapies into clinical trial.

It is expected that this emerging technology will significantly progress the sector in the UK, as unique challenges are overcome. For example, in scoping the project it became clear that important quality and regulatory issues would need to be expertly addressed in order to maximise the utility of the bank worldwide.

For further details see: MHRA

Posted by Tim Sandle

Tuesday, 20 October 2015

Rapid Microbiology Tests Market



Rapid microbiology tests expedite the determination of a microorganism causing a symptomatic infection and hence help in selection of a method for its elimination. Rapid diagnosis of an infection with accuracy enables patient for early commencement of therapy and implementation of appropriate infection control measures. Such tests also reduce redundancy of un-required diagnostic testing and treatment. Current rapid microbiology tests include various genomic testing methodologies such as nucleic acid hybridization, polymerase chain reaction (PCR) technologies or nucleic acid sequencing. These tests are highly sensitive and specific in nature and provide accurate outcomes.

Clinical applications

  • Automated identification & susceptibility systems
  • Automated blood culture systems
  • Streptococcus infection rapid tests
  • Sexually transmitted diseases rapid tests
  • Respiratory disease rapid tests
  • Gastrointestinal rapid test
  • Other automated & rapid microbiological tests
For further details see Rapid Micro.

Scott Sutton


Scott Sutton, one of the foremost microbiologists, passed away while attending the PDA Microbiology Conference at North Bethesda.

Scott was an inspiration to me and I learnt a great deal from his work. His writings on Microbiology laboratories, plate counting, and disinfectants, in particular were especially useful.

He was a pioneer and a founding father of modern day pharmaceutical microbiology. Dr. Sutton was one of the founders of the Pharmaceutical Microbiology Forum.

Dr. Sutton had over 30 years of experience in the GMP pharmaceutical, medical device, cosmetics and personal products industries with extensive publications and presentations. His expertise included:
  • Quality Assurance / Quality Control
  • GMP and Good Compounding Practice (GCP)
  • Contamination Control
  • Environmental Monitoring
  • Microbiological Laboratory Investigations (OOS)
  • Laboratory Management and Operations
  • Microbiology-related Project Management
Posted by Tim Sandle

Monday, 19 October 2015

Settle plate exposure under unidirectional airflow


Settle plates play an important part in the environmental monitoring programme and for the assessment of microbial settlement at key locations within cleanrooms, particularly when situated within unidirectional airflow devices. It is important that the exposure time of the settle plate is assessed to ensure that the proportion of weight loss (through the loss of moisture) does not result in a loss of growth-promoting properties. A second important concern is with avoiding cracks in the agar which might render reading sections of the exposed plate impossible. This paper outlines a case study to assess the exposure time through microbial growth promotion.

In relation to this key aspect of environmental monitoring, Tim Sandle has written a paper which has been published in the European Journal of Parenteral & Pharmaceutical Sciences.

The reference is:

Sandle, T. (2015) Settle plate exposure under unidirectional airflow and the effect of weight loss upon microbial growth, European Journal of Parenteral & Pharmaceutical Sciences, 2015; 20 (2): 45-50

To view a copy, please contact Tim Sandle

Posted by Tim Sandle