Sunday, 30 June 2013

Update to European hand sanitization standards



The two main hand disinfectant standards within the European Union have been updated.:

EN 1499:1997

Has been replaced with:

EN 1499:2013 Chemical disinfectants and antiseptics. Hygienic handwash. Test method and requirements (phase 2/step 2)

And:

EN 1500: 1997

Has been updated with:

EN 1500:2013- Chemical disinfectants and antiseptics. Hygienic handrub. Test method and requirements (phase 2/step 2)

The first, EN1499 relates to hygienic handwash, and the second, EN 1500, relates to hygienic hand disinfection. Both are based on reducing the counts of bacteria on artificially contaminated hands.

In addition, the following standard relating to the preservation of test strains has also been modified:

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
Posted by Tim Sandle

Saturday, 29 June 2013

Rapid method of pathogen identification

Researchers at the University of Toronto have created an electronic chip that can analyze blood and other clinical samples for infectious bacteria at very fast speeds. The new technology, reported in the journal Nature Communications, can identify the pathogen in a matter of minutes, and looks for many different bacteria and drug resistance markers in parallel, allowing rapid and specific identification of infectious agents.

The researchers developed an integrated circuit that could detect bacteria at concentrations found in patients presenting with a urinary tract infection. One key to the advance was the design of an integrated circuit that could accommodate a panel of many biomarkers.

For further details, see:

Brian Lam, Jagotamoy Das, Richard D. Holmes, Ludovic Live, Andrew Sage, Edward H. Sargent, Shana O. Kelley. Solution-based circuits enable rapid and multiplexed pathogen detection. Nature Communications, 2013



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Posted by Tim Sandle

Friday, 28 June 2013

Validation of disinfectants


An important aspect of the selection and evaluation of disinfectants is the disinfectant validation programme. After a disinfectant has been chosen based on its chemical properties and expected performance/ effectiveness, each disinfectant should be validated to ensure its efficacy.

In relation to this, Tim Sandle has written an overview of the different stages of disinfectant validation and of the key criteria to observe. The review has been published in European Medical Hygiene.

Here is an extract in relation to European tests:

“A suspension test is a test designed to measure the efficacy of a disinfectant against selected microorganisms in the planktonic state after a predetermined contact time. Two standards are published within Europe in order to examine this: EN 1040 to measure bactericidal activity and EN 1275 to measure fungicidal activity. The basic suspension test is a simple, limited test of the product and is performed in order to determine minimum standards. In many ways the basic suspension test only serves to confirm the manufacturer’s data within the testing laboratory. Indeed, many facilities elect to audit the manufacturer and to review the manufacturer’s data in lieu of conducting the basic suspension test at their own premises.”

The reference is:

Sandle, T. (2012). Ensuring Contamination Control: State of the art techniques to establish the efficacy of disinfectants, European Medical Hygiene, Issue 2, November 2012, pp37-43.

To obtain a copy, please see European Medical Hygiene.
Posted by Tim Sandle

Thursday, 27 June 2013

Bacterial nomenclature

Changes in taxonomy or further analysis of bacterial strains may lead to a change in nomenclature. Further information on bacterial nomenclature changes can be found on the List of Prokaryotic Names with Standing in Nomenclature (LPSN), which can be accessed online at LPSN.

Posted by Tim Sandle

Wednesday, 26 June 2013

Quality Risk Management and Environmental Monitoring


Cleanrooms in which biotechnology pharmaceutical processing takes place are subject to environmental monitoring. The frequency at which such monitoring should be performed can be difficult to determine. This paper uses quality risk assessment methods to construct a framework for determining monitoring frequencies and illustrates the suitability of the framework through a case study.

The above refers to a PDA Journal paper written by Tim Sandle, concerning the application of Quality Risk Management to environmental monitoring.

Here is the abstract:

“Environmental monitoring programs are essential for pharmaceutical facilities in order to assess the level of environmental control. For biotechnology facilities there is little advice as to the frequency at which viable environmental monitoring should be conducted. This paper outlines an approach, based on the principles of quality risk management, for the development of a framework from which monitoring frequencies can be determined. This involved the identification of common hazards and the evaluation those hazards in terms of the severity of contamination and the probability of contamination occurring. These elements of risk were evaluated for different cleanrooms and the relative risks ranked. Once the risk scores were calculated, the methods for detecting risks within the cleanrooms were assessed. Risk filtering was then used to group different cleanrooms based on their relative risks and detection methods against predetermined monitoring frequencies. Through use of case study examples, the paper presents the model and describes how appropriate frequencies for the environmental monitoring of cleanrooms can be set.”

The reference is:

Sandle, T. (2012) Application of Quality Risk Management To Set Viable Environmental Monitoring Frequencies in Biotechnology Processing and Support Areas, PDA Journal of Pharmaceutical Science and Technology November/December 2012 vol. 66 no. 6 560-579

For further details, see PDA.

Posted by Tim Sandle

Tuesday, 25 June 2013

New types of antibiotics being investigated


Researchers are currently embarking on a major project where over forty different substances are being screened to see if they can be utilized as potent antibiotics.
A research report describes how researchers are examining forty-six previously untested molecules as potential antibiotics. Each of these chemicals targets and disrupts an important step in the process of protein synthesis in bacteria, thereby making the bacteria incapable of replicating. Essentially this stops growth and therefore an infection from spreading.
Although there are forty-six potential chemicals, the researchers began by testing around 663,000 different molecules against a strain of E. coli bacteria and monitored how the chemicals affecting the growth and survival of the bacterium.
The more successful chemicals were then tested against the bacteria Shigella, known to cause food poisoning. This genus is related to Salmonella and to the organism that causes anthrax (Bacillus anthracis), which sometimes can be lethal in humans and other animals.
Currently one molecule appears very effective. The molecule is called KKL-35. This molecule appears to inhibit the growth of very distantly related bacteria and may have the greatest potential as a universal antibiotic.
The research is being conducted by Kenneth Keiler, an associate professor of biochemistry and molecular biology at Penn State. The latest research has been published in the journal PNAS in a paper titled “Small molecule inhibitors of trans-translation have broad-spectrum antibiotic activity.”

Posted by Tim Sandle

Monday, 24 June 2013

ICH Q4B Annex 14: Bacterial Endotoxin Tests

ICH guideline Q4B Annex 14 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bacterial endotoxins tests – general chapter has been adopted by the European Medicines Agency, according to the ECA.

The document allows for Ph.Eur. 2.6.14. Bacterial Endotoxins, JP 4.01 Bacterial Endotoxins Test, and USP General Chapter <85> Bacterial Endotoxins Test, can be used as interchangeable in the ICH regions. The proviso is that the gel-clot test remains the reference test.

Furthermore, the USP, JP, and Ph.Eur. reference standards are considered interchangeable as they have been suitably calibrated against the WHO (World Health Organization) International Standard for Endotoxin.

To view the document go to EMA

Posted by Tim Sandle

Sunday, 23 June 2013

Multi-disciplinary review on antimicrobial resistance in medicine


An interesting review has been published in Frontiers in Microbiology. The paper is titled "A brief multi-disciplinary review on antimicrobial resistance in medicine and its linkage to the global environmental microbiota", written by Cantas et al.

The discovery and introduction of antimicrobial agents to clinical medicine was one of the greatest medical triumphs of the 20th century that revolutionized the treatment of bacterial infections. However, the gradual emergence of populations of antimicrobial-resistant pathogenic bacteria resulting from use, misuse, and abuse of antimicrobials has today become a major global health concern. Antimicrobial resistance (AMR) genes have been suggested to originate from environmental bacteria, as clinically relevant resistance genes have been detected on the chromosome of environmental bacteria. As only a few new antimicrobials have been developed in the last decade, the further evolution of resistance poses a serious threat to public health. Urgent measures are required not only to minimize the use of antimicrobials for prophylactic and therapeutic purposes but also to look for alternative strategies for the control of bacterial infections. This review examines the global picture of antimicrobial resistance, factors that favor its spread, strategies, and limitations for its control and the need for continuous training of all stake-holders i.e., medical, veterinary, public health, and other relevant professionals as well as human consumers, in the appropriate use of antimicrobial drugs.

To view the paper, see Frontiers.

Posted by Tim Sandle

Saturday, 22 June 2013

Faster Method to Identify Salmonella Strains


A new method can reduce by more than half the time it takes health officials to identify Salmonella strains, according to researchers in Penn State's College of Agricultural Sciences.

Currently most public-health laboratories use a technique called pulse field gel electrophoresis, or PFGE, to subtype Salmonella strains, and it normally takes one to three days to identify a specific strain.
The new method focuses on two virulence genes and two novel regions of Salmonella DNA called clustered regularly interspaced short palindromic repeats, or CRISPRs. With the method, the researchers devised a form of multi-virulence-locus sequence typing, or MVLST, that can detect strain-specific differences in the DNA at these four locations.

This allows scientists to identify subtype Salmonella strains in half the time or less compared with the current methods.

For further details, refer to the following paper:

N. Shariat, M. K. Kirchner, C. H. Sandt, E. Trees, R. Barrangou, E. G. Dudley. CRISPR-MVLST Subtyping of Salmonella serovar Newport Outbreak Isolates and Determination of the Relationship Between CRISPR-MVLST and PFGE, Journal of Clinical Microbiology, 2013

Posted by Tim Sandle

Jerome Karle, father of crystallography has died


Chemist Jerome Karle, who shared the 1985 Nobel Prize in Chemsitry for his help in developing the now-ubiquitous imaging technique of X-ray crystallography has died aged 94.

X-ray crystallography is a method used for determining the atomic and molecular structure of a crystal, in which the crystalline atoms cause a beam of X-rays to diffract into many specific directions. By measuring the angles and intensities of these diffracted beams, a crystallographer can produce a three-dimensional picture of the density of electrons within the crystal.

X-ray crystallography has revealed the structure and function of many biological molecules, including vitamins, drugs, proteins and nucleic acids such as DNA. X-ray crystallography is still the chief method for characterizing the atomic structure of new materials and in discerning materials that appear similar by other experiments
Karle developed the technique with colleague Herbert Hauptman, with whom he had attended City College in New York in the 1930s. Following World War II, the duo took a mathematical approach to problem of imaging individual molecules, publishing their initial X-ray crystallography result, based on the pattern of light reflected when X-ray beams are shined on a crystalized molecule, in the 1950s. But their work was not immediately accepted. In time, though, the work became recognized and accepted and has led to many important applications and discoveries.

To read more about Jerome Karel's work, see the New York Times obituary.
Posted by Tim Sandle

Friday, 21 June 2013

Helping Authors find the perfect journal for their paper

Elsevier  have launched a new tool to help authors find the right journal for their paper. The new Journal Finder tool is accessible from www.elsevier.com/authors and has just gone live in BETA version. The tool is designed to:
  • Help less experienced authors to select suitable journals for their papers
  • Enable authors working across multidisciplinary fields to identify possible journals
  • Highlight journals that offer open access options, and provide information on publication speeds and impact factors
The Journal Finder tool is aligned with Elsevier's goal to help authors get published in the best possible journal as fast as possible. Sandra Yee, Dean, University Library System, Wayne State University, U.S., said: "The Journal Finder tool as envisioned by Elsevier will provide substantive data and more specific information... thereby aiding both the faculty members and the librarians." 

Posted by Tim Sandle

Thursday, 20 June 2013

Single-use technology


"In the biopharmaceutical industry, single-use technology is rapidly replacing the age-old practice of reusing the devices after decontamination. Adoption of the new practice is economic, it saves time, and most importantly– it eliminates the risk of contamination. This article introduces the subject, describes the types of systems available and touches upon the primary method of sterilising them (by irradiation)."

This is taken from an introductory article by Tim Sandle into single-use disposable sterile technology as used within the pharmaceutical industry. The article has been published in the magazine Industry 2.0.

The article can be read on-line here.

The reference is:

Sandle, T. (2013). Single-Use: Sterile Disposable Technology, Industry 2.0, Vol.12, Issue 9, pp45-47

Posted by Tim Sandle

Wednesday, 19 June 2013

Electrophoresis (USP)

The latest edition of the Pharmacopeial Forum, which publishes text for comments ahead of changes to the USP, has a new draft text relating to electrophoresis. The details are:

PHARMACOPEIAL FORUM VOL. 39 No.3 (May– Jun 2013)

Chapter 726    Electrophoresis

(Revision proposal target, USP37-NF32 1S)

The Biological Analysis Expert Committee recommended omitting this general chapter due to lack of useful, specific methods with system suitability criteria that are expected in a mandatory (below 1000) test chapter used in the monographs.

For further details see the PF.

Posted by Tim Sandle

Tuesday, 18 June 2013

Out Of Trend Results


An out-of-trend (OOT) result that does not follow the expected trend, either in comparison with previous results collected from past history. This article discusses the possible statistical approaches and implementation challenges to the identification of OOT results.

In relation to this important subject for pharmaceutical sciences, V.J.V.Prasad has written an on-line article for the website Ask About Validation.

The article can be viewed here: OOT.

Posted by Tim Sandle

Monday, 17 June 2013

New edition of the USP


A new edition of the USP has recently been issued: USP36-NF31. The changes of interest are:

General Chapters

Listed are items in which changes have been made to existing official text.

General Tests and Assays

Chapter 1        Injections

Revision to the following sections: Foreign and Particulate matter.

Physical Tests and Determinations

Chapter788     Particulate Matter in Injections

Revision to the following sections: Introduction and Method 1 Light Obscuration Particle Count Test.

Chapter 921    Water Determination

Revision to the following sections: Method I (Titrimetric and Method II (Azeotropic – Toluene Distillation), General information.

Chapter1051   Cleaning Glass Apparatus

Introduction and appendix have been added.

Chapter 1197 Good Distribution Practices for Bulk Pharmaceutical Excipients [NEW]

NF31: Monographs

Caprylic Acid [NEW] (Octanoic acid)

For further details, see USP.

Posted by Tim Sandle

Sunday, 16 June 2013

ATCC® Bacteriology Culture Guide

The American Type Culture Collection (ATCC) have produced a useful guide containing general technical information regarding bacterial growth, propagation, preservation, and application.

The guide is available to those who register on the ATCC website. For details go to ATCC.

Posted by Tim Sandle

Saturday, 15 June 2013

Antibiotic Resistance Using Crystallography


Scientists at the University of Bristol, together with collaborators at the University of Aveiro, Portugal, have solved the structure of an enzyme that breaks down carbapenems , antibiotics 'of last resort' which, until recently, were kept in reserve for serious infections that failed to respond to other treatments.

Carbapenemases are members of the group of enzymes called beta-lactamases that break down penicillins and related antibiotics.

Using molecular dynamics simulations, Professor Adrian Mulholland in the School of Chemistry and Dr Jim Spencer in the School of Cellular and Molecular Medicine, showed how a particular type of carbapenemase enzyme reorients bound antibiotic to promote its breakdown and render it ineffective.

In a study published in the Journal of the American Chemical Society (JACS), the scientists combined laboratory experiments with computer simulations to investigate how one particular type of carbapenemase recognises and breaks down antibiotics.

Using X-ray crystallography, they obtained two 'snapshots' of the carbapenemase in the act of breaking down a carbapenem antibiotic. This static structural information was used as a starting point for simulations that modelled the motions of the enzyme and the bound antibiotic.

The simulations showed how the carbapenemase reorients the drug to promote its breakdown. In beta-lactamases that cannot break down carbapenems, this rearrangement cannot happen, and so the enzyme cannot break down the antibiotic. Knowing this should help in designing new drugs that can resist being broken down.

For further details, see:

Fátima Fonseca, Ewa I. Chudyk, Marc W. van der Kamp, António Correia, Adrian J. Mulholland, James Spencer. The Basis for Carbapenem Hydrolysis by Class A β-Lactamases: A Combined Investigation using Crystallography and Simulations. Journal of the American Chemical Society, 2012; 134 (44)

Posted by Tim Sandle

Friday, 14 June 2013

Pharmaceutical Water Guideline (WHO)


An update from the European Compliance Academy on the revised WHO standard for pharmaceutical water.

The current TRS 970 of the WHO comprises an updated version of the guideline regarding the manufacture and distribution of water for pharmaceutical use. The range of the guideline's scope has been narrowed by excluding the processing small amounts of water in pharmacies. A key change is the indication that the design of a water system is important for avoiding microbiological growth in the system (in the previous version only the sanitisation was mentioned as control measure). The authors also emphasise the importance of the appropriate capacity to ensure a sufficient re-circulation.

A further change is that the pharmaceutical manufacturer must be responsible for ensuring that the feed water has drinking water quality. If the in-coming water is not of a suitable quality, the manufacturer must take suitable measures in a step prior to the actual treatment to guarantee this quality.

With regard to purified water (AP) the revision now mentions the possible treatment components (reverse osmosis and EDI). The amendment states (similar to the USP) that warning limits are supposed to be based on operational experience.

To view the revised standard, go to: ECA

Posted by Tim Sandle

Thursday, 13 June 2013

Pharmeuropa 25.2

A new edition of Pharmeuropa: 25.2, has recently been published. This is the forum where draft European Pharmacopeia monographs are published for public comment.

If no further revision is required the draft monograph is proposed to the European Pharmacopoeia Commission if adopted an implementation date is given and this is about one year after the adoption of the monograph. The monograph is then published in the European Pharmacopoeia (or supplement). The monograph is published about 6 months after adoption. Therefore draft text appearing in Pharmeuropa may not become official for up to 2 years. Those monograph’s adopted will be highlighted in reviews of the European Pharmacopoeia or supplements.

In the new edition, there is one change of interest:

Monograph 3.2.1.        Glass Containers for Pharmaceutical Use

The main changes are:

Production: a section has been introduced to address the risk related to potential delamination of glass containers. This is done by raising awareness of the pharmaceutical manufacturers of the factors contributing to the phenomenon which resulted in a number of recalls. Although only a very small number of containers was affected it is an important factor to be considered for both the glass manufacturers and the pharmaceutical users.

Harmonisation with ISO 4802 – 1 and 4802 - 2: adjustment was made to avoid ambiguities with ISO. This includes the addition of an additional volume specification for containers of a volume of 2 to 3 mL in Table 3.2.1-3 and Table 3.2.1-7.

Test for surface hydrolytic resistance – determination by flame spectrometry: some editorial modifications were made to clarify the text.

Hydrolytic resistance of glass grains: alternative grinding device introduced to include state of the art equipment resulting in increased reproducibility of sample preparation.

Need for control of specific components that may be toxic for chronic use and vulnerable patient groups: this information was already proposed in a previous publication in Pharmeuropa 24.2

For further details, see EDQM.

Posted by Tim Sandle

Wednesday, 12 June 2013

Disinfectant validation

Disinfectants used in hospitals and biopharmaceutical facilities should be selected with care, not least to show that they are compatible with the detergents used to clean, with the surfaces intended to be disinfected and with each other. In an exclusive extract from ‘The CDC Handbook: A Guide to Cleaning & Disinfecting Cleanrooms’, Dr Tim Sandle has outlined the essential requirements for the validation of disinfectants, focusing upon European standards.


The article focuses on the European approach to disinfectant validation. The standard European approach for disinfectant validation consists of a basic suspension test, a quantitative suspension test (with low and high levels of organic material added to act as ‘interfering substances’) and a two part simulated-use surface test.

The extract has been published in the journal EuropeanMedical Hygiene. To subscribe to the journal go to:

If anyone would like a copy of the article, please contact Tim Sandle.

The reference is:

Sandle, T. (2012). Ensuring Contamination Control: The validation of disinfectants, European Medical Hygiene, November 2012, pp33-39

Posted by Tim Sandle

Tuesday, 11 June 2013

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, here.

Posted by Tim Sandle

Monday, 10 June 2013

Copper can destroy norovirus


New research from the University of Southampton shows that copper and copper alloys will rapidly destroy norovirus, the highly-infectious sickness bug. Initial research suggest that norovirus van be rapidly destroyed on copper and its alloys, with those containing more than 60 per cent copper proving particularly effective. The contamination model used was designed to simulate fingertip-touch contamination of surfaces.

Professor Bill Keevil, Chair in Environmental Healthcare at the University of Southampton and lead researcher, presented his work at the American Society for Microbiology's 2013 General Meeting.

Norovirus can remain infectious on solid surfaces and is also resistant to many cleaning solutions. Potentially copper alloy surfaces can be employed in high-risk areas such as cruise ships and care homes, where norovirus outbreaks are hard to control.

For further details, see the University of Southampton

Posted by Tim Sandle

Sunday, 9 June 2013

IEST: contamination control guidelines

Not directly related to pharmaceuticals, but possible of wider interest those involved with controlled environments.

The Institute of Environmental Sciences and Technology (IEST) has released a new Recommended Practice, IEST-RP-CC046.1: Controlled Environments (Aerospace, Non-cleanroom), which contains contamination control guidelines from piece-part acquisition to product delivery.

The guideline contains contamination control criteria to support successful performance of high-reliability products and associated subassemblies, which are not required to be produced in cleanrooms. A key factor in protecting such products from contamination is the development of a Contamination and Foreign Object Damage (FOD) Control Program.

This first-edition Recommended Practice is focused on the aerospace industry and provides a minimum set of requirements for a basic contamination control programme, which could be tailored to specific products and processes.

“This Recommended Practice provides a set of basic guidelines for producing high-reliability products using affordable methods to control production environments and prevent contamination,” said Rick George, Chairman of the IEST Working Group that produced this document. “These guidelines, which have been sorely lacking in many industries, make it easier for smaller companies to provide clean products in a cost-effective manner.”

Using a “clean as you go” approach, IEST-RP-CC046.1 sets out standardised procedures to mitigate contamination during production operations and preserve product cleanliness through assembly, test, storage, and transportation.

The goals of this approach are to: prevent intrusion of contaminants from outside the controlled area; minimise the generation of contaminants within the controlled area; and remove contaminants before they can attach to critical surfaces.


For further details see IEST

Posted by Tim Sandle

Saturday, 8 June 2013

ECHA authorisation list: cleanroom chemicals

Chemicals used in cleanrooms have been added to the European Union’s ‘authorisation’ list over environmental health concerns.
A listing requires cleanrooms wanting to use these chemicals to seek permission from the European Commission, advised by the European Chemical Agency (ECHA). The chemicals are potassium dichromate and trichloroethylene, which will require authorisation for use from September 2017 and April 2016 respectively.

Potassium dichromate, used to make chromic acid for cleaning glassware and as an oxidising agent in various laboratories, was listed for being carcinogenic, mutagenic and toxic to reproduction. Trichloroethylene, used for cold-cleaning of fabricated metal parts and as a solvent in vapour-degreasing, is a carcinogen.

ECHA has clarified that cleanrooms applying for authorisation can continue using these chemicals after these ‘sunset dates’ while waiting for a Commission decision.

Source: Cleanroom Technology

Posted by Tim Sandle

Friday, 7 June 2013

Main Street Family Pharmacy in Tennessee

The U.S. Food and Drug Administration (FDA) has identified bacterial and fungal growth in samples from two unopened vials of preservative-free (PF) methylprednisolone acetate (MPA) 80 mg/mL, 10mL vials form Main Street Family Pharmacy.

The microbial growth was seen in samples from two separate lots (batches). Additional samples and lots of PF MPA are still under evaluation, as well as other sterile products produced by Main Street. FDA, in partnership with the U.S. Centers for Disease Control (CDC), is working to identify the exact species of fungus and bacteria observed in the vials. FDA has received reports of adverse events, including skin and soft tissue abscesses. To date, FDA is not aware of any cases of meningitis associated with Main Street’s preservative free methylprednisolone acetate for injection.

The FDA asks health care providers and consumers to report adverse events or quality problems experienced with this or any Main Street products to the FDA’s MedWatch Adverse Event Reporting program
Posted by Tim Sandle

Contamination Control in Healthcare Product Manufacturing

A new PDA / DHI book of interest has been published. The book is titled ‘Contamination Control in Healthcare Product Manufacturing, Volume 1’ and it has been edited by Russell Madsen, Jeanne Moldenhauer.

The description for the book reads:

“Contamination Control in Healthcare Product Manufacturing, Volume 1, edited by Russell E. Madsen and Jeanne Moldenhauer, is primarily focused on microbiological contamination and the methods used to monitor and control it, a secondary focus looks at chemical contamination that may result from the use of cleaning and disinfecting agents. There is something for almost everyone who has responsibility for developing or using microbiological contamination control programs and systems.

In this first book of the contamination control series, you will be provided with a wealth of information that can aid you in understanding the sources of contamination, types of control measures that can be used, methods to use when contamination occurs and regulatory expectations for management of these systems.”

The chapters which make up the book, written by leading industry experts, are:

1.Introduction by Russell E. Madsen and Jeanne Moldenhauer
2.The Contamination Control Plan in Facility Validation by Scott Sutton
3.Facility Design and Control: Materials and Design by Gary Devloo
4.Facility Design and Control: HVAC by John Pinto
5.Facility Design and Control: Personnel by Anne Marie Dixon
6.Facility Design and Control: Cleaning and Sanitization by Anne Marie Dixon
7.Single-Use Systems for Contamination Control by Maik W. Jornitz
8.Selecting an Appropriate Process Cleaning Detergent by Mark Compo
9.Disinfectant Qualification by Ziva Abraham
10.Environmental Monitoring for Non-Sterile Operations by Miriam Rozo
11.Fungal and Bacterial Spores: Contamination and Disinfection by Jim Polarine, Carol Bartnett and Dan Klein
12.Microbial Control: Mold by Brian G. Hubka
13.Sterility Test Failure Investigations by Jeanne Moldenhauer
14.Endotoxins by Karen Zink McCullough
15.An Audit Approach to Address Microbial Contamination in Process Equipment by Paul Lopolito and Elizabeth Rivera
16.Impact of Biofilms in Contamination Control by Lucia Clontz
17.Deviations and Investigations by Frank Settineri
18.Contamination Control Risk Assessment by Tim Sandle
19.The Role of In-House Microbial Isolates in Contamination Control by Robert Westney

For further details about the publication, see the PDA.

Posted by Tim Sandle

Thursday, 6 June 2013

How to Write Like a Scientist


A shorter blog post. Adam Ruben has written an amusing, but equally very insightful article titled 'How to Write Like a Scientist'. It is hosted by Science.
Here is an extract:
"Why can’t we write like other people write? Why can’t we tell our science in interesting, dynamic stories? Why must we write dryly? (Or, to rephrase that last sentence in the passive voice, as seems to be the scientific fashion, why must dryness be written by us?)"
Read the full article here: Ruben article
Posted by Tim Sandle

Wednesday, 5 June 2013

USP General Chapters on Sterilization


Two new proposed sterilisation chapters have appeared in the Pharmacopeial Forum 39 (3) for comments.

These are:

USP - 1229.7 Gaseous Sterilization

The use of sterilizing gases for the preparation of materials and equipment is in widespread application for items that are susceptible to damage by heat or radiation processes. Many polymeric materials, especially medical devices, are sterilized in this manner, as is non-pressure-rated process equipment.

As outlined in Sterilization of Compendial Articles 1229, the chapter addresses such processes as ethylene oxide, ozone, and chlorine dioxide. The majority of gas sterilization processes employ ethylene oxide (EtO), and procedures for use with other gases generally are patterned after EtO practices.

The chapter also addresses validation requirements and routine process control.

USP – 1229.8 Dry Heat Sterilization

Dry heat sterilization is a process employed for heat-stable items that are unsuited for steam sterilization because of either an absence of water (nonaqueous liquids and powders) or requirements for absolute dryness following processing (product contact parts for nonaqueous products).

This chapter addresses the sterilisation control cycle, validation requirements, biological indicators and routine process controls.

For further details, see the PF.

Posted by Tim Sandle

Tuesday, 4 June 2013

New compounds to curb Staph infection


Writing online in the Journal of the American Chemical Society, a group led by University of Wisconsin-Madison chemistry professor Helen Blackwell describes agents that effectively interfere with the "quorum sensing" behavior of Staphylococcus aureus.

The research team identified peptide-based signaling molecules that effectively outcompete the native molecules the bacterium uses to communicate and activate the genes that cause disease.

Bacteria use quorum sensing to assess their population density and coordinate certain behaviors. They do so through the use of pheromone-like chemicals, which bind to receptors either in the bacterial cell or on its surface and tell it if there are enough companion bacteria around to switch on genes that perform certain functions. In the case of Staphylococcus aureus, quorum sensing activates toxin production, manifesting disease in the host.

Interfering with bacterial quorum sensing to stymie disease is considered a promising new antibiotic strategy.

For further details, refer to the following paper:

Yftah Tal-Gan, Danielle M. Stacy, Mary K. Foegen, David W. Koenig, Helen E. Blackwell. Highly Potent Inhibitors of Quorum Sensing in Staphylococcus aureus Revealed Through a Systematic Synthetic Study of the Group-III Autoinducing Peptide. Journal of the American Chemical Society, 2013

Posted by Tim Sandle