Friday 31 May 2013

Can bacteria adapt to nano-silver?

Researchers from UNSW have cautioned that more work is needed to understand how micro-organisms respond to the disinfecting properties of silver nano-particles, increasingly used in consumer goods, and for medical and environmental applications.

However, antimicrobial action of nanosilver is not universal Furthermore, according to a new study, overexposure to silver nano-particles can cause potentially harmful organisms to rapidly adapt and flourish.

For further details, please see the following paper:

Cindy Gunawan, Wey Yang Teoh, Christopher P. Marquis, Rose Amal. Induced Adaptation ofBacillus Antimicrobial Nanosilver. Small, 2013

Posted by Tim Sandle

Thursday 30 May 2013

Rapid assessment of fungi using solid-phase cytometry

Rapid quantification of viable fungi in hospital environments using solid-phase cytometry

Indoor fungal contamination is a major source of nosocomial diseases in hospitals. The monitoring of environmental fungal contamination is strongly recommended, especially for outbreak investigation in epidemic situations and during building construction and renovation work.

To examine this further, a study has been conducted whereby a combination of two recent technologies for sampling (Coriolis air sampler) and rapid detection of viable airborne fungi with a solid-phase cytometry (SPC) system have been examined.

To see the outcome, refer to the following application note and paper.

Méheust D, Le Cann P, Gangneux JP. Rapid quantification of viable fungi in hospital environments: analysis of air and surface samples using solid-phase cytometry, Journal of Hospital Infection, 2013 Feb;83(2):122-6. doi: 10.1016/j.jhin.2012.10.004. Epub 2013 Jan 11.

Posted by Tim Sandle

Wednesday 29 May 2013

World MS Day

Today, may 29th, is multiple sclerosis (MS) day. Held annually at the behest of the Multiple Sclerosis International Federation, the campaign is taking place for the fifth time this year and aims to educate the public on the nature of the condition and its impact on the lives of sufferers.

Multiple sclerosis (MS) is one of the most common neurological disorders and causes of disability in young adults. It is found in every country in the world, where epidemiological data exists. It affects an estimated two million people worldwide, although it is likely that many hundreds of thousands more remain undiagnosed*. Most people with MS are diagnosed between the ages of 25 and 31, with approximately twice as many women diagnosed than men. It is not yet known what causes the disease, and as yet there is no cure.

The severity of the course of MS as well as the symptoms can vary widely among individuals. These can include blurred vision, weak limbs, tingling sensations, unsteadiness and fatigue. For some people, MS is characterised by periods of relapse and remission, while for others it has a progressive pattern. Some people may feel and seem healthy for many years following diagnosis, while others may be severely debilitated very quickly. For everyone, MS makes life unpredictable.

In terms of the actual day, summary of what’s going on in a few countries this year:
  • The Brazilian Association of MS (ABEM) will celebrate World MS Day with lunch and live music at ABEM HQ and a TV appearance by neurologist Liliana Russo.
  • Cyprus MS Association will hold a press conference in Nicosia.
  • MS Society of Canada will illuminate Niagara Falls in red from 9 to 10.30pm. They’re also organising a social at the local Crowne Plaza overlooking the Falls to watch the spectacle.
  • The Finnish MS Society is organising a festival in Helsinki for World MS Day. Singer Saija Varjus will perform at the event which will be hosted by MP Jani Toivola. Other activities will include an acrobatics performance and a solidarity chain in the form of ‘MS’.
  • The MS Society of Norway will hold a conference on disability and employment in Oslo. Politicians and representatives of health authorities, labour unions and disability organisations are expected to attend the conference. Visit the Society’s website for details.
  • Swedish MS Foundation is holding an information event in Lund, Sweden. Click here to look at the event programme and to register for the event.
  • AEDEM will be forming chains of solidarity in Madrid and other major cities in Spain to mark World MS Day 2013. Their young persons group AEDEM Young will also encourage young people to join their ‘The Missing Piece is You’ campaign and raise awareness on social media. 

For further details, see the official campaign site

Posted by Tim Sandle

Antifungal polyvinylidene fluoride (PVDF) in cleanrooms

High technology cleanroom environments often contain polymeric sheets, coatings, wall coverings, and polymeric foam for insulation. These are used to create lightweight structures, walls, partitions, ceilings, and pipe and ducting insulation. Many of these materials are antifungal, due to low surface energy.

Such material can be assessed using the ASTM G21-96 (2002), Standard Practice for Determining Resistance of Synthetic Polymeric Materials to Fungi.

In looking at this further, Ron Partridge has written an article examining the latest developments and standards. It can be found on-line, hosted by Controlled Environments

Posted by Tim Sandle

Tuesday 28 May 2013

What is a Surface Active Agent?

A Surface Active Agent can be described as a substance that can modify the surface properties of liquids or solids. In cleaning applications, these agents work at the boundary layer between soil and solvent. For aqueous based products, surfactants aid water overcoming its difficulty in dissolving oils and greases. By design, surfactant molecules have two chemical groups. On one end, there is an hydrophobic component that is attracted to the oil/grease. The other group is hydrophilic and compatible with water. Due to the strong interactions between the water molecules arising from dispersion forces and hydrogen bonding acting cooperatively, the hydrocarbon tail is squeezed out of the water. Hence the tail is usually termed hydrophobic.

In a cleaning solution, the hydrophobic end of the surfactant molecule orients toward the soil. Many surfactant molecules will attack the soil, breaking it up into small pieces and completely surrounding it. The hydrophilic ends of the surfactant molecules project into the solvent (i.e. water), causing the soil to be broken up, removed from the surfaces, lifted, and suspended into the cleaning solution. The outside ends on the detergent molecule chains are attracted to water, and the inside ends prefer oil, forming a cluster of surfactant molecules around the oil. In addition to the assembly at the interfaces, surfactants can undergo a self-assembly process known as micellization resulting in a sequestering of the hydrophobic end.

Surfactant technology represents a vibrant and challenging area of physicochemical science where the exact mechanisms of well-established processes are often not fully understood or are at least the subject of continued debate. This is partly due to the complex nature of even the simplest commercially available surfactants—there is still a degree of empiricism when selecting surfactants for certain applications.

Posted by Tim Sandle

Monday 27 May 2013

Air and surface particulate levels from cleanroom mats

Contamination control, especially controlling the level of airborne particulates, is of great importance within cleanrooms. One of the means to reduce particle levels from footwear is with the use of cleanroom mats. However, many cleanroom mats are either ineffective in removing particles from shoes, or an elevated level of particles are generated when the mat is removed. In contrast, the use of polymeric flooring can lead to a reduction in particle generation.

This is based on some research undertaken by Tim Sandle and the findings have been published in a new paper. The abstract reads:

This paper describes a study undertaken in a biopharmaceutical manufacturing facility, which examined particle levels from the footwear of personnel entering a cleanroom and after stepping onto a cleanroom mat. The study compared six adhesive cleanroom mats and polymeric flooring and considered the change in the number of particles on footwear (uncovered shoes and shoes covered with an overshoe) before and after personnel had traversed cleanroom flooring. From this comparison, the level of reduction was greatest from the footwear of staff who had walked across the polymeric flooring. The study also assessed the level of particles produced when the top layer of a cleanroom mat was removed, and these data are presented for information purposes.

The reference is:

Sandle, T. (2012). Examination of air and surface particulate levels from cleanroom mats and polymeric flooring, European Journal of Parenteral & Pharmaceutical Sciences 2012; 17(3): 110-119

The website for the EJPPS journal can be found here.

Posted by Tim Sandle

Human Skin Fungal Diversity

The National Institutes of Health researchers have sequenced the DNA of fungi at skin sites of healthy adults to define the normal populations across the skin and to provide a framework for investigating fungal skin conditions. Fungi, along with bacteria, form part of the human skin microbiome.

The researchers collected samples at 14 body sites from 10 healthy adults. DNA sequencing of the fungi in the samples identified fragments of DNA, called phylogenetic markers, which can be counted and used to distinguish one type of fungus from another. The sequencing efforts generated more than 5 million markers, from the samples, representing more than 80 fungal types, or genera.

The researchers identified fungi from two phyla, Ascomycetes and Basidiomycetes, as part of the normal fungal census at the 14 skin sites. The researchers found that a single type of fungus, belonging to the genus Malassezia, is predominant on the head and trunk. Hands, which harbor a great diversity of bacteria, are home for relatively few types of fungi. In contrast, feet, including toenails, heels and toe webs contain tremendous diversity.

The most common types of fungi were:

Malassezia spp. 62 isolated, including:

Malassezia globosa
Malassezia restricta
Malassezia sympodialis

Pencillium spp. 25 isolated, including:

Pencillium chyrsogenum
Pencillium lanosum

Aspergillus spp. 19 isolated, including:

Aspergillus candidus
Aspergillus terreus
Aspergillus vesicolor

Less than 5 isolated of each of the following:

Alternaria spp.
Candida spp.
Chaetomium spp.
Chryssoporium spp.
Cladosporium spp.
Mucor spp.
Rhodotorula spp.
Tricophyton spp.

The most complex site, the heel, is home to about 80 genus-level types of fungi. The researchers found about 60 types in toenail swab samples and 40 types in samples from the webs of the toes. Sites with moderate fungal diversity are inside the bend of the arm, inside of the forearm and palm, with each location supporting 18 to 32 genera of fungi. The head and trunk body sites, including the back, back of the neck, inside the ears, behind the ears, and between the eyebrows, have far fewer fungi types, with just two to 10 genera each.

The research team compared fungal diversity data with the skin bacteria on the same healthy adults. They found that while arms have high measures of bacterial diversity, they have lower fungal diversity. They found the reverse to be true for sites on the feet. Core body sites had neither a high bacterial diversity nor a high fungal diversity. The researchers had previously shown that bacterial diversity can be predicted by whether skin is moist, dry or oily. Fungal diversity, instead, seems to depend upon where a particular skin site is on the body.

The new study appears in an online issue of Nature. The paper is titled “Topographic diversity of fungal and bacterial communities in human skin.”

Keisha Findley, Julia Oh, Joy Yang, Sean Conlan, Clayton Deming, Jennifer A. Meyer, Deborah Schoenfeld, Effie Nomicos, Morgan Park, Heidi H. Kong, & Julia A. Segre1 (2013): Topographic diversity of fungal and bacterial communities in human skin, Nature, 498,367–370 doi:10.1038/nature12171

Posted by Tim Sandle

Saturday 25 May 2013

Potential Novel Treatment for Influenza Discovered

An experimental drug has shown promise in treating influenza, preventing lung injury and death from the virus in preclinical studies, according to University of Maryland School of Medicine researchers publishing in the journal Nature.

The scientists found that a drug called Eritoran can protect mice from death after they have been infected with a lethal dose of influenza virus.

The findings are of particular interest to scientists now that the latest deadly strain of flu, H7N9, is spreading in China.

For further details refer to the following on-line open access journal:

Kari Ann Shirey, Wendy Lai, Alison J. Scott, Michael Lipsky, Pragnesh Mistry, Lioubov M. Pletneva, Christopher L. Karp, Jaclyn McAlees, Theresa L. Gioannini, Jerrold Weiss, Wilbur H. Chen, Robert K. Ernst, Daniel P. Rossignol, Fabian Gusovsky, Jorge C. G. Blanco, Stefanie N. Vogel. The TLR4 antagonist Eritoran protects mice from lethal influenza infection. Nature, 2013

Posted by Tim Sandle

Friday 24 May 2013

International pharmaceutical harmonization

Tim Sandle offers his thoughts on the development of pharmaceutical regulatory harmonization, outlining the benefits and coming changes.

What are the benefits of harmonization?

The benefits of harmonization are multi-faceted. The benefits include ensuring that there is one standard, or set of standards, across different countries and, where applicable, across different industries. This helps with trade. It also helps consumers, patients and clients to know that the equipment produced or tests conducted have been undertaken to a supra-national or internationally recognized benchmark.

Harmonization also allows technologists and scientists an opportunity to shape and adjust guidelines and methods to make sure that they are meaningful and generate the most appropriate results in a consistent manner. Consistency is key really; it is important to know that tests are reliable and that results can be reproduced.

Harmonization benefits drug manufacturers in being able to share data, studies, process technologies; and to use established test methods. This can lead to time and cost savings.
There are also benefits to consumers and patients in either getting faster access to medicines, or access to previously unavailable medicines, and to safer and better quality products.
To draw an example, the World Health Organization has been an institution which has arguably promoted harmonization for the longest time across a range of health and drug initiatives. Recognition in relation to life-enhancing drugs in relation to HIV/AIDS, TB, and malaria are cogent examples. There are, however, a multitude of other areas in the pharma and healthcare fields which fall outside the WHO scope and where harmonization would be an advantage.

Acknowledging these various activities, I would surmise the benefits using three words: quality, safety and efficacy.

What are the ultimate goals of the harmonization movement?

First off, harmonization is part of globalization and a reflection of the greater interconnectedness of nations and people which has been evolving with a fast momentum over the past few decades. This underpins many of the initiatives.

The goals of harmonization will be different depending upon which stakeholder offers their view. Politicians and businesses will see economic advantages, and to an extent with quality and safety.  Scientists, like myself, will see harmonization as the means by which quality can be inbuilt into tests and processes to peer reviewed international standards.

The goals is in finding ways for regulatory representatives from drug manufacturers and researchers to work together to raise standards and to push through drug approvals.

 What are the main challenges of harmonization?

The overarching challenge is with integrating national standards with international standards in ways which will be universally acceptable. This task leads to the main challenges which are, foremost, dealing with the different views of national committees and attempting to move beyond the parochialism of "we've always done it this way".  After these come the various technical challenges in reaching points of agreed understanding and developing agreed methodologies.  Then comes the complexities of the review process and finalization.  Good review practices help to promote transparency and consistency.
Once these barriers have been overcome, there are challenges between what the scientific consensus may be and the resultant costs to industry.

One of the reasons that the international cleanroom standards ISO 14644 parts 1 and 2 were sent back to the drawing board were because those interested in the statistics of sampling and with a focus upon contamination control proposed, wisely in my view, that the number of locations for monitoring within a cleanroom should be increased to make the sampling of airborne contaminants more representative. This was opposed, however, my certain pharmaceutical companies who saw the added costs to their operations. Over this there was, to a degree, a divide between the European delegation and the North American delegation. The dispute has pushed the revision of the standard back at least eighteen months.

What the obstacles standing in the way of harmonization?

Time is, as with many major projects, an obstacle. Time in the sense that some areas of harmonization take years and years to achieve. Drawing on cleanrooms again, it took over a decade to move away from the old Federal Standard (FS209E) to ISO 14644. Even then, this was in two waves, with most of the world adopting the new standard in 1999, whereas the US waited until 2004.

Time, in the other sense, relates to competing demands. There are only so many projects which can be run at any one time.

Another obstacle is lack of interest or will, which is why there are several different American and European standards .

A further obstacle is failure to achieve scientific consensus. One example here are the complexities of mutual recognition (which have a political dimension as well as a scientific one).

Drawing upon a specific technical example: the standard for the evaluation of disinfectants, the European 'norms' focus heavily on evaluating what happens when a disinfectant solution is challenged with a micro-organism (how quickly is the microbe destroyed and by what quantity); whereas the US standards are more interested in what happens when micro-organisms are on surfaces and whether the disinfectant and wiping process can effectively inactive or remove the microbes.  The consequence of this is that a simple biocide, used to prepare process equipment, may not be recognized in one region of the world or another.

 Which areas of drug development and commercialization should be harmonized ?

A key area is with clinical trials and with overcoming the quite considerable delays in getting products approved across multiple countries. This involves licensing and regulatory agencies in working together. Likewise there is still work to be done in relation to marketing applications, to avoid putting together multiple applications, invariably with the same data presented differently, to different regions.

There is much that can be done in building upon the work of regional agencies. A number of bodies. like APEC (across Asia) and PANDRH (South America), have helped to facilitate research and trade within their respective regions. What is important is taking this to the next level and for these bodies to work more closely together.

What are some examples where harmonization has been successful and useful?

The most successful examples of harmonization, in my view, relate to the pharmacopeias. With the biological chapters the European, United States and Japanese pharmacopeias have worked effectively together in relation to sterility testing (a key batch release test for aseptically filled products), microbial limits (which applies to many non-sterile products, like creams and ointments where there is a concern with pathogens), and with bacterial endotoxin (which is a test for microbial by-products which can cause fever).

For these developments, various expert groups have worked very effectively together. A parallel example is with the ISO standards, although there is not always a compulsion to take these up and given the vast range these can be picked and chosen to some extent. With ISO quality standards, like ISO 9001, however, these have near universal acceptance and the resultant quality audit initiatives have helped to shape drug safety.

Another key area is with the ICH (International Conference on Harmonization). The ICH kicked things off with breaking down barriers in relation to regulated markets. The ICH has also made some progress with stability data to assess the shelf-life of medicines, which enables studies in one region to be recognized and accepted by another.

More recently it has done some sterling work in relation to quality management and risk management. This has introduced a whole set of tools for evaluating and mitigating risks to the industry and a common set of objectives. This has been to the benefit of more efficient processes and, ultimately, patient safety.

A further example has been with regulatory guidance and inspection. Here a body like PIC/S (Pharmaceutical Inspection and Co-operation Scheme) has been instrumental. PIC/S has traditionally been strong in co-ordinating regulatory best practice across European and Australian territories, but its course of action was strengthened considerably when the FDA joined in 2011.

Posted by Tim Sandle

Thursday 23 May 2013

Cleanroom safety

While a primary purpose of most controlled environments is to protect the product or process from contamination generated by workers, protecting workers from hazards generated by cleanroom processes—and the cleanroom itself—is paramount.

Cleanrooms are complex systems, with tight floor plans, sophisticated equipment, and hazardous materials. Workers are subject to hazards from the physical environment (electrical, heat, fire). Depending on the facility, workers also may be subject to dangerous chemicals and biological materials.

Safety practices should be part of all standard operating procedures. In addition, all workers should be well trained in emergency procedures in the event of fire, power failure, chemical spill, or other catastrophic event.

This cleanroom tip was taken from "Safety First," which appeared in the November/December 2012 issue of Controlled Environments.

Posted by Tim Sandle

Wednesday 22 May 2013

Pharmig News #51

The latest edition of Pharmig News has been published (issue 51). This is the magazine of the Pharmaceutical Microbiology Interest Group.

Inside the current issue is a short introduction to bacteria and growth requirements (by Dr Tim Sandle) and a paper titled “Induction of iron regulated proteins during siderophore produciton by halotolerant Rhizobacteria and Rhizophere fungi isolated from saline agricultural sites”, written by Puja Hajela and B P Dave.

The issue also includes the regular regulatory update and details of courses and publications of interest to pharmaceutical microbiologists.

Copies will have been sent to members. Individual copies are available to purchase.

For further details, see Pharmig.

Posted by Tim Sandle

Ensuring Sterility of Parenteral Products

Pharmaceutical technology is hosting an interview on the important subject of ensuring the safety of pharmaceutical products with James Agalloco from Agalloco & Associates, Tim Sandle from Bio Products Laboratory and Benoît Verjans from Aseptic Technologies.

The lead reads:

“An interview with several executives from various pharmaceutical companies, including James Agalloco from Agalloco & Associates, Tim Sandle from Bio Products Laboratory and Benoît Verjans from Aseptic Technologies, is presented. When asked about the common sources of contamination, Agalloco refers to the personnel. Verjans says that the challenges in sterilization include the contamination prevention. Sandle views the disposable technologies as important advances to reduce contamination.”

The in-depth discussion can be read on-line, via Pharmaceutical Technology.

Alternatively, a version of the discussion can be read in the April editions of Pharmaceutical Technology (Volume 37, Number 4) and Pharmaceutical Technology Europe (Volume 25, Number 4).

Posted by Tim Sandle

Tuesday 21 May 2013

Clean Air and Containment Review

A new edition of the important journal Clean Air and Containment Review has been issued.

Among the highlights in the fourteenth issue are:
  • Removal efficiency of high efficiency air filters against microbe-carrying particles (MCPs) in cleanroomsBill Whyte et al
  • Energy saving opportunities in cooling systems for cleanroomsGordon Farquharson
  • Fans with EC (electronically commuted) motorsGunter Streng
  • New Cleanroom Energy Management Standard:BS 8568:2013 - Cleanroom energy - Code of practice for improving energy efficiency in cleanrooms and clean air devicesDick Gibbons
  • Revision of ISO 14698 - Biocontamination control:Personal reflections on what might be desirableTim Sandle
For further details, see CACR.

Posted by Tim Sandle

Monday 20 May 2013

Cleanroom wipes: a source of particle counts?

A new paper of interest, in relation to cleanrooms, particles and contamination control has been published. The paper looks at particles generated from cleanroom wipes.

The abstract reads:

“Cleanroom wipes, saturated with disinfectant, are commonly used within pharmaceutical grade cleanrooms as part of contamination control programmes. Whilst standards are in place for the testing of wipes for particle shedding, there is a limited data relating to the particle generation from wipes when they are used in practical conditions. This paper outlines a study that was undertaken of three different cleanroom wipes of the particles generated as the wipes were used. The study was undertaken within an isolator in order to minimise the background particle levels. The study showed that cleanroom wipes designed for ISO class 5 / EU GMP Grade A use are suitable for the those areas, but that wipes which are not certified for use in higher grade cleanrooms should not be used in those areas due to the high level of particles generated.”

The reference is:

Sandle, T. (2013). In situ study of particles generated from the use of pharmaceutical grade cleanroom wipes, European Journal of Parenteral and PharmaceuticalSciences, Vol. 18, No.1, pp5-11

Posted by Tim Sandle

Sunday 19 May 2013

Risk Management in Pharmaceutical Microbiology

 Pharmaceutical Manufacturing has published an article by Tim Sandle titled 'Risk Management in Pharmaceutical Microbiology'. The article looks at risk assessment techniques, such as HACCP and FMEA, from a microbiological perspective.

"Within microbiology, a shift is taking place from simple laboratory studies toward greater use of risk assessment and management. Sometimes these approaches form part of a drug company's total quality system, sometimes they exist as standalone techniques. The most important guidelines for pharmaceutical microbiology are described in ICH Q9, including the tools of FMEA (Failure Mode and Effects Analysis); FTA (Fault Tree Analysis); and HACCP (Hazard Analysis Critical Control Points).

The two most commonly used within microbiology are HACCP (which originated in the food industry) and FMEA (which was developed for the engineering industry). This article explores these two approaches, first with a description of HACCP, followed by a description and case study of FMEA in sterility testing

The article can be found here, and the reference is:

Sandle, T. (2012). "Risk Management in Pharmaceutical Microbiology: at look at how HACCP and FMEA can make a difference in the pharma micro lab.", Pharmaceutical Manufacturing Magazine on-line.

The article is an edited extract from the book 'Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices', edited  by Madhu Raju Saghee, Tim Sandle and Edward C. Tidswell.

The book can be purchased from Amazon (US) here:

Posted by Tim Sandle

Saturday 18 May 2013

Metallothioneins and fungal pathogens

Metallothioneins, proteins able to capture metal ions, play a major role in the virulence of Cryptococcus neoformans, a fungal pathogen which causes severe infections in immunodeficient and immunocompetent individuals (AIDS patients, transplant receivers, and so on) This is one of the main conclusions of the research published on the journal Cell, Host & Microbe.

Metallothioneins (MT) are low molecular weight, cysteine-rich proteins. They can bind metal ions and act as chelating agents -- compounds which capture metals -- to capture and distribute biologically interesting metals (copper, zinc, cadmium, quicksilver, etc.). MTs are very heterogeneous and polymorphic, and can be found in any type of organism (prokaryotes, fungi, plants, vertebrates, etc.), in which they facilitate metal detoxification processes and help to modulate the of the organism's physiological response against a lack or excess of metals.

The new research, carried out with mice, shows that when MTs have been modified and are not able to bind metals, the pathogen is unable to infect host cells.

Refer to the following paper for more details:

Chen Ding, Richard A. Festa, Ying-Lien Chen, Anna Espart, Òscar Palacios, Jordi Espín, Mercè Capdevila, Sílvia Atrian, Joseph Heitman, Dennis J. Thiele. Cryptococcus neoformans Copper Detoxification Machinery Is Critical for Fungal Virulence. Cell Host & Microbe, 2013

Posted by Tim Sandle

Cleanroom Management in Pharmaceuticals and Healthcare

Cleanroom Management in Pharmaceuticals and Healthcare

Edited by Tim Sandle and Madhu Raju Saghee.

Everything you need to know about the operation and management of cleanrooms.

In 26 Chapters and over 600 pages this book provides a unique tool to help you achieve regulatory compliance. It first creates a foundation in history and established practice and then helps you understand how state of the art technology and engineering solutions can deliver the best practice and so provide reliable systems performance.

An essential read for practitioners in cleanroom technology.

For further details see: cleanrooms


1. Introduction by Tim Sandle and Madhu Raju Saghee
2. History and development of cleanrooms by Tim Sandle
3. Cleanroom standards and GMP requirements by Mark Hallworth
4. Design and construction of pharmaceutical cleanrooms by Alexander Fedotov
5. Air handling systems for the protection of pharmaceutical manufacturing processes by Hans Schicht
6. Cleanrooms in hospitals by Alexander Fedotov
7. Commissioning and qualification of cleanrooms by Kevin Beauchamp and Miroslav Tonovski
8. Cleanroom certification and ongoing compliance by TimSandle and Madhu Raju Saghee
9. Fundamentals of pharmaceutical isolators by Brian Midcalf, John Neiger and Tim Sandle
10. The choice of isolators: A risk-based decision by Didier Meyer
11. Validation concepts in pharmaceutical aseptic application isolators by Rajesh Thempadiyil
12. Risk-based product and occupational exposure control in multi-product facilities by Julian Wilkins
13. Future of aseptic processing by James L Drinkwater
14. Aseptic process simulations/media fills by Marco Budini
15. Microbial risk management during aseptic manufacture by Tim Eaton
16. Airflow studies and airflow mapping by Tim Sandle,Marco Budini and T Rajesh
17. Cleanroom contamination sources and control measures by Eric Strauss
18. Particle counters and particle counting by Tony Harrison
19. Environmental monitoring in cleanrooms by Tim Sandle and Madhu Raju Saghee
20. Cleaning and disinfection practices by Tim Sandle and Madhu Raju Saghee
21. Cleanroom clothing byMatts Ramstorp
22. Quality assurance in hospital pharmacies by Richard Bateman
23. Building Management Systems for cleanroom process parameters monitoring and control by Sunil Chand Singhai and Rajesh Thempadiyil
24. Energy management and sustainable cleanrooms byNigel Lenegan and Ulla Thomsen
25. Auditing cleanroom operations by Tim Sandle and MadhuRaju Saghee
26. Developments in cleanroom technology by Tim Sandle and Madhu Raju Saghee

Published by Euromed

Posted by Tim Sandle

Friday 17 May 2013

Antibiotic resistance news

New scientific research published in the journal PLoS Biology shows that bacteria can evolve resistance more quickly when stronger antibiotics are used.

Researchers from the University of Exeter and Kiel University in Germany treated E. coli with different combinations of antibiotics in laboratory experiments.The researchers found that the rate of evolution of antibiotic resistance speeds up when potent treatments are given because resistant bacterial cells flourish most during the most aggressive therapies.

This happens because too potent a treatment eliminates the non-resistant cells, creating a lack of competition that allows resistant bacteria to multiply quickly. Those cells go on to create copies of resistance genes that help them rapidly reduce the effectiveness of the drugs. In tests this effect could even cause E.coli to grow fastest in the most aggressive antibiotic treatments.

To read more, see the University of Exeter research brief.

Posted by Tim Sandle

Thursday 16 May 2013

Guidance on disinfectants from Health Canada

Health Canada has issued a Draft Guidance Document: Disinfectant Drugs (2013).

The CDC Handbook: A Guide to Cleaning and Disinfecting Cleanrooms

According to Health Canada:

"This document has been created to provide a more user friendly and comprehensive overview of the safety and efficacy requirements considered necessary to obtain market authorization of disinfectants and disinfectant-sanitizers regulated under the Food and Drugs Act and Food and Drug Regulations. The proposed revisions to this guidance document draw upon the long standing regulatory and scientific basis for the evaluation of disinfectant products by other regulators, most notably the United States Environmental Protection Agency (U.S. EPA) and the United States Food and Drug Administration (FDA), the guidance for North American Free Trade Agreement (NAFTA) labelling of hard surface disinfectants, and ongoing Organization for Economic Cooperation and Development (OECD) harmonization goals."

For interest to microbiologists and cleanroom users is that intention that the following is included:
  • well established test methods [for example (e.g.) Association of Analytical Communities standard methods) and more recent test methods (e.g. towelette protocols];
  • the inclusion of more detailed efficacy requirements to specify the recommended criteria for assessing disinfectant drugs, in tables based on microorganism type;
To access, see Health Canada.

Posted by Tim Sandle

Wednesday 15 May 2013

FDA Releases Draft Guidance on Labeling Safety

The FDA has issued the following draft guidance:

"Guidance for Industry Safety Considerations for Container  Labels and Carton Labeling Design to  Minimize Medication Errors".

The introduction to the document states:

"The purpose of this guidance is to help prescription drug and biologic product manufacturers minimize medication errors associated with their products. This guidance focuses on safety aspects of the container label and carton labeling design, and provides a set of principles and  recommendations for ensuring that critical elements of a product’s container labels and carton labeling are designed to promote safe dispensing, administration, and use of the product.

This guidance applies to prescription drug and CDER-regulated biological products, including the following:
  • Prescription drug products marketed under an approved new drug application (NDA) or abbreviated new drug application (ANDA); 
  • Prescription drugs marketed without an approved NDA or ANDA; and 
  • Biological products marketed under an approved biologics licensing application (BLA)."
Further inside, the FDA has several recommendations on
  • Proprietary, Established, and Proper Names
  • Product Strength
  • Route(s) of Administration
  • Warnings for Critical Information
  • Expiration Dates
  • Bar Codes
  • National Drug Code Numbers
  • Controlled Substance Schedule
To access the document, see FDA.

Posted by Tim Sandle

Tuesday 14 May 2013

Detergent choices for endoscope reprocessing

The first stage of endoscope cleaning involves the use of detergents. Without adequate cleaning, the disinfection stage will not be completed successfully and the risk of microbial survival becomes greater. There are two classes of detergent: enzymatic and non-enzymatic. There are advantages and disadvantages with each type, and the choice between them should be made by way of risk assessment.

In relation to the above, Tim Sandle has written an article for The ClinicalServices Journal.

Sandle, T. (2012). ‘Detergent choices for endoscope reprocessing’, The Clinical Services Journal, Volume 11, Issue 8, pp71-75

The article can be read on-line, although readers need to register with the journal beforehand. Go to Clinical Services Journal

Posted by Tim Sandle

Monday 13 May 2013

What is an antimicrobial stewardship programme (ASP)?

Optimisation of antimicrobial use is the overriding goal of any antimicrobial stewardship programme (ASP). Ultimately, it is about finding the balance between effective use and overuse – equating to managing proper selection, duration, dose, and route of administration. This process should aim to enhance clinical outcomes by improving the efficacy of identified drugs and lowering the risk of unintentional consequences associated with antimicrobial use. In tandem with improved patient care, the programme should result in cost efficiencies associated with decreased use of antimicrobials, minimised ADEs and appropriate length of stay (LOS). To successfully achieve these aims, an ASP should include methods for:
  • ·         Tracking and reducing antimicrobial resistance.
  • ·         Encouraging appropriate treatment patterns.
  • ·         Collaboration between physicians, pharmacy, laboratory personnel and infection preventionists with best patient outcome in mind.
  • ·         Ongoing and formalised education of staff and providers.

Posted by Tim Sandle

Sunday 12 May 2013

Cleaning endoscopes

The cleaning of endoscopes is an important part of contamination control in hospitals and in avoiding the transmission of hospital acquired infections. Cleaning involves the use of detergents. The selection of detergents is an important one, with the choice centred on enzymatic and non-enzymatic types.

To explore the benefits and risks of using either enzymatic and non-enzymatic detergents, Tim Sandle has written an article for Infection Control. There reference is:

Sandle, T. (2012). Keeping in control: the use of detergents for endoscope cleaning, Infection Control, August 2012, pp4-5

For details see Infection Control

Posted by Tim Sandle

Saturday 11 May 2013

Education resource for schools - Marvellous Microbes

The Society for General Microbiology has issued an educational resource for schools called “Marvellous Microbes - A visit to the dentist (Issue 3)”.

In this issue of Marvellous Microbes a boy, curious to know why he needs to brush and floss his teeth twice a day, takes a trip to the dentist who introduces him to the plaque acid producing bacteria that live on our teeth. The comic includes an experiment to try at home looking at the function of fluoride toothpaste in our daily brushing routine.

The resource can be downloaded from the society’s webpage here: SGM

Posted by Tim Sandle

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