Tuesday, 30 April 2013

Cleaning endoscopes: Considering the risks and benefits of enzymatic and non-enzymatic detergents

The cleaning of critical medical devices, such as endoscopes, is of great importance both in terms of protecting the patient and for preventing the transmission of hospital-acquired infections (HAIs). For the cleaning of endoscopes there are typically two different types of detergents which can be used – enzymatic and non-enzymatic. Each type of detergent has advantages and disadvantages, ranging from efficacies relating to the removal of contamination to low-level allergenic risks to the people responsible for cleaning and subsequent disinfection.

In order to understand how detergents clean and the important differences between enzymatic and non-enzymatic detergents, Tim Sandle has written an article for the journal ‘Inside Hospitals’. A copy of the article can be read on-line on the websites ‘Hospital Bulletin’ and ‘Inside Hospitals’.

These can be accessed here:


The reference is:

Sandle, T. (2012). “Cleaning endoscopes: Considering the risks and benefits of enzymatic and non-enzymatic detergents”, Inside Hospitals, June 2012, pp14-15

Posted by Tim Sandle

Monday, 29 April 2013

Free webinar: USP 1116 and its impact on Microbiology




Pharmig (Pharmaceutical Microbiology Interest Group) are hosting a free webinar on Wednesday 1st May 2013.

Please register for USP 1116 and its impact on pharmaceutical microbiology on May 1, 2013 2:00 PM BST at:

Pharmig Webinar

This is Pharmig's first webinar and it is free to attend.

The session will be presented by Dr. Tim Sandle and will cover:

• An in depth review of changes to USP 1116
• How will the recent changes to USP 1116 affect you?
• How are these changes viewed by the different regulators around the world? Including, a European perspective.
• Key changes including references to the international cleanroom standard ISO 14644

After registering, you will receive a confirmation email containing information about joining the webinar.


Posted by Tim Sandle

WHO issues guidelines on non-sterile process validation


The World Health Organisation (WHO) has issued guidelines for the revision of the supplementary guidelines on good manufacturing practices: non-sterile process validation. The closing date for comments is May 24th, 2013.

The introduction to the document states:

"This guideline allows for different approaches in process validation. The principles described in this guideline are applicable to non-sterile finished pharmaceutical dosage forms. Thorough knowledge of product and process development studies; previous manufacturing experience; and quality risk management (QRM) principles are essential in the all approaches to process validation as the focus is now on the life-cycle approach. The life-cycle approach links product and process development, validation of the commercial manufacturing process and maintenance of the process during routine commercial production."

In the document it is explained that manufacturers should plan towards implementing the new approach in process validation that should consist of three phases in the product life-cycle.
  • Phase I. Process design
  • Phase II. Qualification and process verificatio
  • Phase IIA. Qualificatio
  • Phase IIB. Continuous process performance verification
  • Phase III. Continued process verification 
The document is designed to form part of the supplementary guidelines on good manufacturing practices: validation. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fortieth report. Geneva, World Health Organization. WHO Technical Report Series, No. 937 (Annex 5), 2006.

To access the document, see WHO.
Posted by Tim Sandle

Sunday, 28 April 2013

Cleanrooms and Air Quality – A Risk - Based Approach

Contamination control is the primary consideration in cleanroom design,however,the relationships between contamination control and airflow are not well understood.Contaminants such as particles or microbes are primarily introduced to cleanrooms by people,although processes in cleanrooms may also introduce contamination.

Based on these risk considerations, Tim Sandle has written a paper on a risk based approach to looking at cleanrooms and air quality. The paper is being hosted by the Irish Cleanrooms Society. 

To find out more and to read the paper, see ICS.

Posted by Tim Sandle

FDA Releases Guidance on Non-Penicillin Beta-Lactam Drugs

FDA has released a new guidance titled “Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination" (April 2013).

In the guidance, FDA stresses the importance of implementing manufacturing controls to prevent cross-contamination of finished pharmaceuticals and APIs with non-penicillin beta-lactam drugs. Beta-lactam antibiotics include the following five classes:
  •  penicillins (e.g., ampicillin, oxacillin) 
  • cephalosporins (e.g., cephalexin, cefaclor) 
  •  penems (e.g., imipenem, meropenem) 
  • carbacephems (e.g., loracarbef) 
  • monobactams (e.g., aztreonam)
In this guidance FDA also provides information regarding the relative health risk of cross-reactivity in the classes of sensitizing beta-lactams (including both penicillin and non-penicillin beta-lactams). FDA states that manufacturers generally should use separate facilities for the manufacture of non-penicillin beta-lactams because those compounds pose health risks associated with cross-reactivity.

According to the document:

"This guidance describes the importance of implementing manufacturing controls to prevent cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with non-penicillin beta-lactam drugs. This guidance also provides information regarding the relative health risk of, and the potential for, cross-reactivity in the classes of sensitizing beta-lactams (including both penicillins and non-penicillin beta-lactams). Finally, this guidance clarifies that manufacturers generally should utilize separate facilities for the manufacture of non-penicillin beta-lactams because those compounds pose health risks associated with cross-reactivity."

For further details, see FDA.

Posted by Tim Sandle

Saturday, 27 April 2013

ICH Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals

A new guideline has been published which may be of interest to readers.

ICH Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk – m7.

The introduction capture the aim of the document and reads:

“This guideline emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in final drug substance or product, taking into consideration the intended conditions of human use.”

For further details, see ICH

Posted by Tim Sandle

Bacteriologist Francois Jacob has died


Bacterial geneticist Francois Jacob died on April 19. Jacob worked with Jacque Monod and Andrew Lwoff on gene regulation, and the three scientists won the Nobel Prize in Physiology or Medicine in 1965.

Jacob undertook work characterizing bacteriophages, viruses that seed DNA into bacterial genomes, where they can lie dormant for long periods before reactivating and killing the host cell. He also confirmed the existence and function of mRNA.

Jacob also worked on the Escherichia coli lac operon, which allows that bacterium to control how much lactose-digesting enzyme it makes by taking into account the amounts of lactose and glucose available. Through this work, Jacob and colleagues demonstrated how genes in a cell are turned off and on.

For more on his work, see the Los Angeles Times.
Posted by Tim Sandle

Friday, 26 April 2013

Bacterial survival in water systems


New research has looked at the ways in which  waterborne bacteria can colonize rough surfaces, even those that have been designed to resist water.

The research has looked at Escherichia coli, which has many flagella that stick out in all directions. The researchers found that these tails can act as biological grappling hooks, reaching far into nanoscale crevices and latching the bacteria in place.

E. coli are equipped with two types of appendages: pili, which are short, sticky hairs, and the whip-like flagella, which are often twice as long as the bacterium itself. Pili had previously been recognized as playing a critical role in the formation of biofilms. These short hairs, up to only a micron in length in E. coli, can stick to surfaces temporarily, while the bacteria secrete a thick slime that holds them permanently in place.

Read more...


ECA hosts successful microbiology conference


The European Compliance Academy conference on Microbiology took place this week (24th and 25th April 2013), in Copenhagen, Denmark.

The meeting featured a fascinating range of topics and interesting speakers, balancing cutting edge research with practical advice along with the latest GMP requirements. 

The meeting opened with a presentation delivered by Dr Friedrich von Wintzingerode on the subject of microbial identification, covering how a new method can be implemented in light of USP chapter 1113.
This was followed by an informative presentation by Barbara Gerten, of Merck, on Microbiology standards, relating USP 1117 to ISO standards, especially for media and water testing.

The next presentation was from Dr David Roesti, offering a practical approach for setting monitoring limits for areas like water testing and environmental monitoring. Next was a second presentation by Dr Wintzingerodr on a risk based approach for biological non-sterile products.

The final sessions of the first day focused on sterility. Dr Christian Vogt outlined the qualification of sterility test isolators, including the use of bespoke biological indicators. Then Dr Jorg Degen described the complexities involved with the sterility testing of combination products.

On the second day UK MHRA inspector Di Morris outlined the importance of out of specification investigations for microbiological tests and added some inspection findings. The second speaker of day two was Dr Michael Reith who offered a rapid microbiological method case study.

Third was Dr Andy Bailey, who looked at the risk management of viruses for biopharmaceutical products.
This wad followed by an approach for hygiene monitoring non sterile environments, by Dr Roman KarasevDr Tim Sandle then discussed fungal contamination of pharmaceutical products, including recent recalls, identification methods and disinfectant qualification. The final speaker was Laure Valognes, who presented in single use systems.

The overall event was excellently organised by the ECA and the agenda was packed full of the major microbiology topics of the moment.

Posted by Tim Sandle

Thursday, 25 April 2013

How Salmonella uses biofilm to survive in hostile environments


New research has shown that in addition to protecting Salmonella from heat-processing and sanitizers such as bleach, biofilms preserve the bacteria in extremely dry conditions, and again when the bacteria are subjected to normal digestive processes.

The research has shown that in moist conditions, Salmonella thrive and reproduce abundantly. If thrust into a dry environment, they cease to reproduce, but turn on genes which produce a biofilm, protecting them from the detrimental environment.

Read more...


World DNA Day

April 25th is World DNA World DNA and Genome Day.

World DNA Day commemorates the 1953 discovery of the double helix structure of DNA and the completion of the Human Genome Project in 2003.

To read more see: DNA

Posted by Tim Sandle

International DNA day


International DNA day is being celebrated on April 25th, the 60th anniversary of the publication of the Molecular Structure of DNA by Watson and Crick.

On April 25th, 1953, James Watson and Francis Crick published one of the greatest biological discoveries of our time. It was so profound that, from solving crimes and finding horse meat in burgers to creating designer babies, we still benefit from – and grapple with – new consequences.

The scientific paper in question, which provided the first explanation of the double-helix structure of DNA, was published in the journal Nature on April 25th, 1953; its publication changed everything about our understanding of the science of genetics.

A copy of the pioneering paper is currently available free-to-view on the Naturewebsite.

Posted by Tim Sandle

Wednesday, 24 April 2013

Draft ISO 14644-12 Cleanrooms and associated controlled environments

The draft international cleanroom standard ISO 14644, Part 12, is now available for public comment. The standard is titled ‘Classification of air cleanliness by nanoscale particle concentration’. The standard can be accessed through national standards bodies and comments need to be made by July 31, 2013.

Nanoscale refers to particles of the range 1 nm to 100 nm. This relates to microelectrics and to some healthcare products.

The standard has been developed following the removal of sections on ultrafine particles from ISO 14644 Parts 1 and 3. These sections have been incorporated, in modified form, in the new document ISO 14644-12.

The new standard relates to the other following standards:
  • ISO 14644-3:2005 Cleanrooms and associated controlled environments -- Part 3: Test methods
  • ISO 15900:2009 Determination of particle size distribution -- Differential electrical mobility analysis for aerosol particles
  • ISO 21501-4:2007 Determination of particle size distribution -- Single particle light interaction methods – Part 4: Light scattering airborne particle counter for clean spaces ISO/TS 27687:2008 Nanotechnologies -- Terminology and definitions for nano-objects -- Nanoparticle, nanofibre and nanoplate
  • ISO 27891 Aerosol particle number concentration -- Calibration of condensation particle number counters
  • ISO/TS 80004-1:2010 Nanotechnologies -- Vocabulary -- Part 1: Core terms

Posted by Tim Sandle

Tuesday, 23 April 2013

Chemical disinfectants and antiseptics - Published standards



Here is the current list of disinfectant standards published in Europe, by the CEN. The European Committee for Standardization (CEN) was officially created as an international non-profit association based in Brussels on 30 October 1975.

  • EN 1040:2005 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)
  • EN 12353:2013 Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
  • EN 1275:2005 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic fungicidal or basic yeasticidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)
  • EN 1276:2009 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1)
  • EN 1276:2009/AC:2010 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1)
  • EN 12791:2005 Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirement (phase 2/step 2)
  • EN 13610:2002 Chemical disinfectants - Quantitative suspension test for the evaluation of virucidal activity against bacteriophages of chemical disinfectants used in food and industrial areas - Test method and requirements (phase 2, step 1)
  • EN 13623:2010 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity against Legionella of chemical disinfectants for aqueous systems - Test method and requirements (phase 2, step 1)
  • EN 13624:2003 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)
  • EN 13697:2001 Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of bactericidal and/or fungicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas - Test method and requirements without mechanical action (phase 2/step2)
  • EN 13704:2002 Chemical disinfectants - Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1)
  • EN 13727:2012 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)
  • EN 14204:2012 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1)
  • EN 14347:2005 Chemical disinfectants and antiseptics - Basic sporicidal activity - Test method and requirements (phase 1)
  • EN 14348:2005 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)
  • EN 14349:2012 Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)
  • EN 14476:2005+A1:2006 Chemical disinfectants and antiseptics - Virucidal quantitative suspension test for chemical disinfectants and antiseptics used in human medicine - Test method and requirements (phase 2, step 1)
  • EN 14561:2006 Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)
  • EN 14562:2006 Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)
  • EN 14563:2008 Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area - Test method and requirements (phase 2, step 2)
  • EN 14675:2006 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1)
  • EN 14885:2006 Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics
  • EN 1499:1997 Chemical disinfectants and antiseptics - Hygienic handwash - Test method and requirements (phase 2/step 2)
  • EN 1500:1997 Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirements (phase 2/step 2)
  • EN 1650:2008 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1)
  • EN 1656:2009 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1)
  • EN 1656:2009/AC:2010 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1)
  • EN 1657:2005 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1)
  • EN 1657:2005/AC:2007 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1)
Posted by Tim Sandle

Monday, 22 April 2013

Human Genome Project: 10 years on


The 10th anniversary of the announcement of the completion of the Human Genome Project was reached during April 2013.

In June 2000 scientists joined U.S. President Bill Clinton at the White House to unveil the Human Genome Project's "working draft" of the human genome—the full set of DNA that makes us human. The project got underway in April 2003.

The Human Genome Project (HGP) is an international scientific research project with a primary goal of determining the sequence of chemical base pairs which make up DNA, and of identifying and mapping the approximately 20,000–25,000 genes of the human genome from both a physical and functional standpoint.

The objective of the Human Genome Project is to understand the genetic makeup of the human species.

The Guardian has a feature on the project, which may be of interest.

Posted by Tim Sandle

Cleanrooms and clean air supply



In the launch issue of European Medical Hygiene, Tim Sandle presents an overview of clean air supply to hospital operating theatres, pharmacy units and cleanrooms.

An extract from the article is:

“There are several different types of clean air technologies and these are applied to different settings. For hospitals the two of interest are the cleanroom, which is applicable to the hospital pharmacy, and the clean zone, which is important to both the pharmacy and operating theatre. For the aseptic preparation and dispensing of medicines, a hospital pharmacy unit will have either a cleanroom with a clean air device within it, or use an isolator. Within the operating theatre, clean air is directed towards the theatre table by a vertical unidirectional airflow (UDAF) unit, which forces clean air downwards in parallel streams.”

The reference is:

Sandle, T. (2012). “An Air of Safety: The application of cleanrooms and clean air devices within the hospital setting”, European Medical Hygiene, Issue 1, August 2012, pp11-17

To find out more about European Medical Hygiene, visit EMH

Posted by Tim Sandle

Sunday, 21 April 2013

Useful science links


Useful Science Links

Posted by Tim Sandle

Names for Life: species database

A good source of up-to-date microbial taxonomy is the website Names for Life.

NamesforLife was founded to solve a long-standing problem in biology: resolution of the ambiguity between nomenclature and biological objects and concepts. NamesforLife technology, N4L, makes names actionable. In a N4L-enabled document or database, when encountering a name, the user clicks or mouses over it and a menu of authoritative information is displayed: an up-to-date historical record of both the name and taxon in its current and prior states and its synonyms; technical and non-technical papers in which the organism is a key subject; information about its availability from biological resource centers, databases holding molecular sequence data; and reliable information regarding its pathogenicity, utility, and safety requirements are made available.

For more details, visit Names for Life

Posted by Tim Sandle

Saturday, 20 April 2013

Global Biodiversity Information Facility

The Global Biodiversity Information Facility (GBIF) was established by governments in 2001 to encourage free and open access to biodiversity data, via the Internet. Through a global network of countries and organizations, GBIF promotes and facilitates the mobilization, access, discovery and use of information about the occurrence of organisms over time and across the planet.

To find out more, visit GBIF

Posted by Tim Sandle

Pharmig's Irish Conference: May 2013


Pharmig’s one-day Conference covering ‘hot topics in Microbiology’ is being held Thursday 16th May 2013 at the Radisson Blu St. Helen’s Hotel, Dublin

Leading experts in industry will be addressing topics such as: Building relationships across departments, risk based strategies in the bio-decontamination of hospital laundry, microbiology issues in the medical device industry, a selection of rapid method technologies and potential applications and effective microbial investigations.

Open discussions sessions will also form part of the meeting – an informal section of the day where delegates can raise questions and seek responses from their peers in a more informal environment.

These will cover: Objectionable organisms and ID micro-sequencing, biofilms strategy, IMB, MHRA, FDA common deficiencies and warning letters and a rapid method discussion session

Please do visit the Pharmig website for more details www.pharmig.org.uk

Posted by Tim Sandle

USP 1116 and its impact on Microbiology


Please register for USP 1116 and its impact on Microbiology on May 1, 2013 2:00 PM BST at:

https://attendee.gotowebinar.com/register/3091644528169260032

This is Pharmig's first webinar and is FREE to all Pharmig contacts.

The session will be presented by Dr. Tim Sandle (Site Microbiologist at BPL) and will cover:

• An in depth review of changes to USP 1116
• How will the recent changes to USP 1116 affect you?
• How are these changes viewed by the different regulators
around the world?
• Key changes include: references to ISO 14644

After registering, you will receive a confirmation email containing information about joining the webinar.

Posted by Tim Sandle

Friday, 19 April 2013

European culture collections


Many of the European culture collections collaborate together through a body called the Common Access to Biological Resources and Information (CABRI). Through the CABRI service, more than 110,000 biological resources from 28 collections can be searched in the same site and through a single query. Searching abilities include queries by scientific name and by strain number and free text search. Search by scientific name includes an option for adding synonyms' support. Through CABRI services, resources can also be pre-ordered on-line by using an electronic shopping cart. In this way, a tight connection between collections and scientists is achieved.

The culture collections include BCCM, CABI, CBS, CRBIP, DSMZ, ICLC, NCCB, NCIMB.

For more details, see CABRI

Posted by Tim Sandle

Thursday, 18 April 2013

WHO cGMP

One of the top discussion blogs available on the Internet is the "WHO cGMP" blog. The site features most of the latest standards and guidelines, and contains invaluable advice for their implementation.

As the site indicates, it covers:

FDA GMP Guidelines Pharma Validation Pharma Process Validations Clean Room Classification 21 CFR Part 11 compliance Clinical Trials, Sterile Aseptic Process Training Sterile Dosage Form,Good Manufacturing Practices Pharmaceutical Companies Pharmaceutical Industry FDA Guide Pharma Regulatory Affairs In Pharmaceutical SOP'S Requirements of Manufacturing Documentation Quality Assurance SOP'S For Microbiology Department Pharma Manufacturing Firm Questions Answers.

And goes onto explain:

"Are you associated with pharmaceutical validation pharma regulatory affairs pharmaceutical manufacturing pharmaceutical process validation and are looking for quality information about pharmaceutical manufacturing and process validation US FDA guidelines Pharmaceutical Current Good Manufacturing practices GMP Guidelines C gmp practices across the world ?

Are you a pharmacist working in Pharmaceutical Regulatory Affairs in a pharmaceutical company, pharmacy, in pharmaceutical manufacturing, Quality assurance ?"

For more information, see the "WHO GMP" site.

Posted by Tim Sandle

Basics of cleanroom design



The aim of the cleanroom contractor must be to provide a complete facility with minimum participation by the customer or end user. The cleanroom contractor has the responsibility to design and construct the cleanroom facility in a timely manner and to come in at or below budget. To do so the contractor must consider the following points:
  • At what cleanliness level and in what locations are cleanliness levels required? This is highly dependent on the type of process which will be conducted in the cleanroom.
  • What floor plan works best for the process being conducted? Does the process require multiple rooms and of what cleanliness level? Is a gowning room or ante room required?Where are the critical work areas located, and how will they be affected by the location of the HEPA or ULPA filters and the airflow pattern in the room?
  • What environmental conditions, such as temperature and humidity, are required in the clean space and will those requirements vary in the future?
  • What are the temperature, humidity, and pressure specifications of the cleanroom? There must be a full understanding of the complexity of HVAC design.
  • What are the heat loads due to number of people and equipment loads in the space?
  • Are pass thru units or air showers required to isolate various areas from cleanroom to cleanroom or noncleanroom to cleanroom?
  • Construction materials for walls, ceilings, and floors and their compatibility with the process requirements must be evaluated. The output from your cleanroom could easily be directly related to the amount the materials out-gas or how well the materials dissipate static electricity.
  • Design the wall system, taking into consideration material required and location and size of doors, windows, and other openings such as return grilles.
  • Is there sufficient space above the proposed ceiling for light troffers and HEPA or ULPA filter units and the required mechanical distribution system?
  • Fire protection and any process requirements from electrical requirements to gas or liquid requirements must be designed and coordinated.
  • Correctly identify the size and location of the filters, the air supply, and the air return to properly distribute clean air throughout the space.
  • Light level must meet customer specific light level needs within the space while meeting OSHA requirements.
  • What are the requirements for process piping or electronic communications with the cleanroom?
  • What temperature, humidity, pressure controls, monitors, and network connections are required?
This useful advice comes from an article by George Pollick, which can be found on the Controlled Environments website.

Posted by Tim Sandle

Wednesday, 17 April 2013

Exploring and exploiting microbiological commons

Strainfo is a relatively new on-line database of microbial taxonomy. The site describes itself as having “largest integrated microbial knowledge base” and from my initial evaluation, it appears very comprehensive and has some good links to research papers, which is useful when checking on new species.

For more details, visit Straininfo

Posted by Tim Sandle

Tuesday, 16 April 2013

PMF newsletter Vol. 19, No.2


A new edition of the essential Pharmaceutical Microbiology Forum Newsletter has been published (Vol. 19, No.2).

The newsletter features two key articles:
  • Tim Sandle discusses mitigation of error in the Limulus amebocyte lysate (LAL) assay, including minimizing and detecting errors and evaluating control data.
  • Sung-Oui Suh et al. from the American Type Culture Collection (ATCC) discuss results of their study to clarify the true taxonomic identity and phylogenetic position of drug testing reference strain ATCC® 2601TM , an organism that has long been classified as Saccharomyces cerevisiae.
To access the latest PMF newsletter, go to: PMF

= Posted by Tim Sandle

BIOS: bacteria database

A good source of information about the latest bacterial species, or even to check the spelling of a species name, is the BIOS database. BIOS is an acronym for ‘Bacterial Insight Orienting System’.

BIOS contains data on 8,242 validly published species and subspecies and 2,000 higher taxa of the world’s Bacteria, Archaea and Cyanobacteria.

Besides taxonomic and strain data, BIOS contains links to further information in the NamesforLife prototype. The BIOS system was developed by a team based at the National Institute for Environmental Studies (Japan) and is part of a collaborative effort that includes contributions by J Euz├ęby and B Tindall.

The taxonomy is based on Release 7.4 of the nomenclatural taxonomy of GM Garrity, TG Lilburn and JR Cole.

To visit the site, go to BIOS

Posted by Tim Sandle

Monday, 15 April 2013

Innovations in Plastic Drive Past, Present and Future Medical Care



Advertorial

Ever stop and look around during a doctor or hospital visit?

Even a cursory look reveals dozens of medical instruments and hygienic tools made with plastics: protective examination gloves, sterile bandages and gauze, syringes that help prevent infection, IV tubes and bags that guard against contamination—all made possible by plastics.

Frankly, plastics so pervade the medical field that we often take them for granted. But recent advances could lead to even more innovations that could really get our attention ... and help people all around the world. Here are some examples:

Plastic Heart

Plastic tubes act like heart valves to let blood in and out of two plastic ventricles in an artificial heart that helps extend the lives of patients waiting for transplants. Implanted in more than 1,000 patients, the plastic heart has extended lives by more than 270 years, according to its manufacturer. Regulators now are reviewing an accompanying mobile power supply carried in a backpack, so suitable patients could leave the hospital and live at home.

Lifesaving Plastic Foam

A novel use of polyurethane foam is being explored to stabilize trauma patients with internal injuries on the battlefield. Governments are studying the use of polyurethane foam to fill injured body cavities following severe internal injury from combat. The foam expands inside the body, conforming to the shape of injured tissue and reducing blood loss, before the surgeon removes the foam in one piece. Based on recent tests, researchers estimate that this technology could significantly boost post-injury survival rates.

Polycarbonate Medical Devices

An extremely tough, clear plastic, polycarbonate now is being used to make transparent surgical tools, such as cannulas (small tubes inserted into the body) that enable arthroscopic surgery. Since polycarbonate is clear, surgeons gain better visibility of sutures and surgical knots during the procedure.

Vaccination Patches

Researchers are developing a plastic skin patch that could replace many painful injections. The patch contains plastic “micro-needles” that dissolve into the skin, painlessly delivering vaccinations for a variety of diseases, including the flu. Patients might even be able to administer the vaccine themselves.

Resorbable Heart Stent

A plastic heart stent can open a clogged artery to restore blood flow to the heart—and then slowly dissolve into the body. This resorbable plastic could eliminate the need for another invasive procedure to remove the stent, as well as reduce the likelihood of blood clots and scarring.

3-D Body Part Printing

Researchers are using a layered assembly manufacturing technique— called “3-D printing”—to create medical devices and implants using plastics. For example, a type of polyester plastic (polycaprolactone) and living cells are combined into a material used to make 3-D printed implants to replace human ear cartilage. The combination of materials makes the body more likely to respond favourably to the implant, according to researchers.

Bacteria-Resistant Plastics

Several newly discovered plastics might contribute to reduced infections. These plastics have “nonstick” surfaces that bacteria aren’t attracted to, which could help prevent contamination from bacteria-laden “biofilms.” The plastics could be used to make catheters or medical equipment to help ward off preventable disease.

Self-healing Prosthetics

Researchers are developing a new plastic “skin” that recognizes when it’s been damaged and responds by healing itself. The plastic skin mimics the flexibility and sensitivity of human skin—it becomes electrically conducive by adding a bit of nickel. The plastic skin can restore its mechanical and electrical properties after being cut ...  and repeat that cycle over and over again. Among other applications, researchers hope the self-healing plastic may be used to manufacture lifelike prosthetic limbs that heal themselves after injury—much the way human skin does.

Printing human ears ... delivering painless vaccines ... reducing blood loss on the battlefield see-through medical devices. Plastics are helping drive innovations in medical care that were only dreams a few years ago.

Today's intelligent plastics are vital to the modern world. These materials enhance our lifestyles, our economy and the environment. For more information visit www.intelligentplastics.ca

Posted by Tim Sandle