Monday 30 November 2015

Risk assessment for aseptic transfer

Aseptic transfer is a wide ranging term, covering the inoculation of agar tubes and plates in a microbiology laboratory to the transfer of items into a cleanroom within a sterile products manufacturing facility or a compounding pharmacy. Across the range of applications the overriding requirement is aseptic technique, to either render the material free of contamination (through bioburden reduction) or to prevent adventitious contamination from operators or the environment.

In a new article for Clean Air and Containment Review, Tim Sandle focuses on the best practices for aseptic transfer within a pharmaceutical facility or pharmacy.

Here contamination can result in product adulteration and lead to a potential risk infection for the patient. In order to minimise the possibility of contamination, a risk-centric approach is required. Given several high profile product contamination events worldwide (some with serious consequences for patients), microbial contamination risks remain ever present and, in some cases, ill-controlled. The article considers the key risks and risk mitigations.

The reference is:

Sandle, T. (2015) Importance of Risk Assessment for a Aseptic Transfer in Pharmaceutical Compounding, Clean Air and Containment Review, Issue 24, pp18-23

For details, please contact Tim Sandle

Posted by Tim Sandle

Sunday 29 November 2015

Unified Microbiome Initiative

A consortium of 48 scientists from 50 institutions in the U.S. are calling for a Unified Microbiome Initiative that would span national cross-institutional and cross-governmental agency support. The group, called the Unified Microbiome Initiative Consortium (UMIC), envisions that a coordinated effort would drive forward cutting edge microbiome research.

A Unified Microbiome Initiative to accelerate microbiome research would unlock new insights, speed translation of discoveries into numerous potential technologies for health, industry, and the environment.

The new group aims to look at: understanding how microbes assemble into communities and what makes them resilient or resistant to perturbation, how genes in the microbiome interact with one another, which genes in the microbiome are associated with which organisms, as well as how we can beneficially harness the microbiomes of humans, animals, plants and environments.

For further details see:

A. P. Alivisatos, M. J. Blaser, E. L. Brodie, M. Chun, J. L. Dangl, T. J. Donohue, P. C. Dorrestein, J. A. Gilbert, J. L. Green, J. K. Jansson, R. Knight, M. E. Maxon, M. J. McFall-Ngai, J. F. Miller, K. S. Pollard, E. G. Ruby, S. A. Taha. A unified initiative to harness Earth's microbiomes. Science, 2015; 350 (6260): 507 DOI: 10.1126/science.aac8480

Posted by Tim Sandle

Saturday 28 November 2015

PDA Technical Report No. 73 Prefilled Syringe User Requirements

Recently released - PDA Technical Report No. 73 (TR 73) Prefilled Syringe User Requirements for Biotechnology Applications discusses the requirements for the 1 mL long glass prefilled syringe (PFS) for biotechnology applications.

Over the past decade, a large number of subcutaneously injected biotechnology drug products have been packaged in PFSs because of the benefits compared to vials or ampules. The benefits of PFSs include reduction of medical dosing errors, reduction in risk of microbial contamination by decreased manipulation prior to injection, and improved compliance due to ease of use. In addition to the patient benefits, PFSs often have lower overfill regulatory requirements than vials, thereby reducing product waste.

This report provides guidance on material selection and evaluation for suitability, syringe preparation and handling (including human factors), and drug product compatibility (physical and chemical) with the syringe materials and mode of delivery. Plastic syringes and ancillary devices, such as autoinjectors, are not within scope.

For further details, see PDA.

Posted by Tim Sandle

Friday 27 November 2015

Guido Rasi takes office as head of EMA

Professor Guido Rasi has taken office as Executive Director of the European Medicines Agency (EMA) today.

Professor Rasi was nominated as Executive Director for a five-year mandate by the Management Board of the Agency on 1 October 2015. He was appointed following his statement to the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) on 13 October 2015.

“I am very happy to be back at the helm of the Agency,” said Professor Rasi on his first day in office. “We are currently undergoing the most significant transformation of the system of medicine development and authorisation that I have seen during my 35-year career in public health, either as a doctor, a researcher or a regulator. It is exciting and challenging to be leading the Agency during this time.”

For further details, see EMA.

Posted by Dr. Tim Sandle

New approach to reduce antibiotic resistance

Researchers have developed a novel mathematical method inspired by Darwinian evolution to use current antibiotics to eliminate or reduce the development of antibiotic-resistant bacteria.

In developing a novel mathematical approach to analyze antibiotic resistance, a research group have shown that the ability of the bacterium E. coli to survive in antibiotics could be either promoted or hindered depending on the sequence of antibiotics given. They discovered that approximately 70 percent of different sequences of 2 to 4 antibiotics lead to resistance to the final drug.

For further details see:

Daniel Nichol, Peter Jeavons, Alexander G. Fletcher, Robert A. Bonomo, Philip K. Maini, Jerome L. Paul, Robert A. Gatenby, Alexander R.A. Anderson, Jacob G. Scott. Steering Evolution with Sequential Therapy to Prevent the Emergence of Bacterial Antibiotic Resistance. PLOS Computational Biology, 2015; 11 (9): e1004493 DOI: 10.1371/journal.pcbi.1004493

Posted by Tim Sandle

Pharmig conference 2015 report

This week the U.K.'s biggest conference dedicated to pharmaceutical microbiology took place in Nottingham. The key themes were risk assessment, coping with aging facilities, and addressing contamination issues. The conference was a success in terms of getting the key messages across: use risk wisely; be proactive about aging facilities; and keep data accurate and secure.

Organized by the Pharmaceutical Microbiology Interest Group (Pharmig), the conference has been taking place for overt twenty years. Pharmig is a not-for-profit microbiology society, organized by a volunteer committee.
The logo screen  welcoming delegates to the Pharmig microbiology conference.
The logo screen, welcoming delegates to the Pharmig microbiology conference.

Read more: by Dr. Tim Sandle

Thursday 26 November 2015

Antarctic warming stimulates diversity of soil fungi

A new study predicts that climate change will have a major impact on life in Antarctica this century. Scientists say that results indicated that by 2100 there would be 25 percent more soil fungal 'species' in the most rapidly warming parts of Antarctica.

For details see:

Kevin K. Newsham, David W. Hopkins, Lilia C. Carvalhais, Peter T. Fretwell, Steven P. Rushton, Anthony G. O’Donnell, Paul G. Dennis. Relationship between soil fungal diversity and temperature in the maritime Antarctic. Nature Climate Change, 2015; DOI: 10.1038/nclimate2806

Posted by Tim Sandle

Wednesday 25 November 2015

The Role of Gut Microbiota in Liver Disease

The role of gut microbiota, along with the corresponding translocation of endotoxin into circulation, has been demonstrated for many diseases including Crohn's Disease, ulcerative colitis, HIV and diabetes. A recent publication in the Journal of Clinical Gastroenterology has extended this to liver disease. Using several different mouse models to simulate liver disease, they found significant differences in the microbiome compared to healthy control mice. Several mechanisms for this link were explored, including an increase in gut permeability leading to an increase in circulating endotoxin. Given that Toll-like receptors are required for sensitivity to liver fibrosis, and the role that endotoxin plays in other inflammatory diseases, this is an especially attractive possibility.

Posted by Tim Sandle

Tuesday 24 November 2015

Identification of Neisseria species

Public health England has issued “UK Standards for Microbiology Investigations ID 6: identification of Neisseria species.”

The genus Neisseria belongs to the family Neisseriaceae. There are currently 25 Neisseria species and 3 subspecies of which may be isolated from humans and animals1. Four species have been reclassified. The clinically important Neisseria species (Neisseria gonorrhoeae, Neisseria meningitidis, Neisseria lactamica and Neisseria cinerea) are relatively easy to identify from the non-pathogenic Neisseria. N. gonorrhoeae and N. meningitidis are the two main pathogens of the group. The other species of Neisseria such as N. lactamica and N. cinerea are generally considered commensals, but have been implicated as causes of infection in patients who are immunocompromised. More recent species to the genus Neisseria are N. oralis, N. shayeganii, N. wadsworthii, N. zoodegmatis and N. animaloris isolated from human clinical samples.

The document provides guidance about the identification of these organisms. To access the document, see Public Health England.

Posted by Tim Sandle

Monday 23 November 2015

Current Methods and Approaches for Viral Clearance

Tim Sandle has written a discussion article for American Pharmaceutical Review on the subject of viral clearance. The abstract reads:

“Complete viral safety, as defined by absolute freedom from extraneous viral agents, is not easy to achieve and some would argue that it is an impossible task due to the difficulties in testing for the full range of pathogenic viruses and residual pathogenicity. The process is also complicated by viral inactivation being rarely linear. It can also be that viruses are subsequently discovered several years after a batch has been manufactured. Therefore, whilst product testing can support control measures in terms of the showing that the probability of viral contamination is low, greater confidence is garnered through viral clearance strategies and associated risk assessment.

This article assesses the key factors for viral clearance and considers the current methods used to remove viral particles from the product stream.”

The reference is:

Sandle, T. (2015) Current Methods and Approaches for Viral Clearance, American Pharmaceutical Review, September / October 2015: 1-4

For a copy, please contact Tim Sandle

Posted by Tim Sandle

Sunday 22 November 2015

SfAM Winter Meeting Psychrophilic and Extremophile Microbiology

Microbiology meeting on: Psychrophilic and Extremophile Microbiology, organised by the Society for Applied Microbiology.

19 January 2016
One Great George Street, Westminster, London.
Posted by Dr. Tim Sandle

Technical Guide for the elaboration of monographs

EDQM has released a revised technical Guide for the elaboration of monographs (7th Edition 2015)

For further details see EDQM

Posted by Tim Sandle

Saturday 21 November 2015

New type of bacteria-powered energy source

As part of the hunt for new types of energy, especially those that are renewable, microbiologists have been examining the properties of marine bacteria. One species, called Cyanothece 51142, is of particular interest.

Read more:

Posted by Dr. Tim Sandle

Friday 20 November 2015

Engineered Particles 'may become Antibiotics of the Future'

“Due to rising threat of antibiotic resistance, there is a pressing need for new approaches to fight harmful bacteria.” As reported via the Infectious Diseases Newsletter: “Now, researchers have been successful in developing engineered particles called "phagemids" that enter targeted harmful bacteria and release toxins that kill them. In a study, they developed a particle that works by targeting and killing specific bacteria without causing the cells to burst and release their toxins. These particles are "called phagemids" because they infect the target bacteria with plasmids.”

For further details, see Infectious Diseases.

Posted by Tim Sandle

Thursday 19 November 2015

Pharmacopeial Forum 41 (6)

A new edition of the Pharmacopeial Forum has been issued.  This is volume 41, issue 6, which covers the period November - December 2015.

Highlights include:

Chapter 151 Pyrogen Test
(Revision proposal target, USP40-NF35)

To encourage the use of in vitro alternatives to in vivo animal tests, a revision is proposed to introduce text into the Introduction of the chapter that allows the use of a validated, equivalent in vitro pyrogen or bacterial endotoxin test in place of the in vivo rabbit pyrogen test, where appropriate. There is no impact on any of the monographs that reference this chapter.

Chapter 1790 Visual Inspection of Injections [NEW]
(Revision proposal target, USP40-NF35)

The General Chapters—Dosage Forms Expert Committee proposes this new chapter to provide guidance on the inspection of injectable drug products for visible particles. The methods discussed are also applicable to detection of other visible defects that may affect container integrity or cosmetic appearance of the product. 

Posted by Dr. Tim Sandle

Wednesday 18 November 2015

WHO Good Data and Record Management Practices

The World Health Organization (WHO) has issued a draft guidance document titled “Good Data and Record Management Practices.” The document is out for public comment.

Medicines regulatory systems worldwide have always depended upon the knowledge of organizations that develop, manufacture and package, test, distribute and monitor pharmaceutical products. Implicit in the assessment and review process is a trust between the regulator and the regulated that the information submitted in dossiers and used in day-to-day decision-making is comprehensive, complete and reliable. Data on which these decisions are based should therefore be complete as well as being accurate, legible, contemporaneous, original and attributable; commonly referred to as “ALCOA”.

The draft discusses the controls necessary for good data management, which include:

A quality risk management approach that effectively assures patient safety and product quality and validity of data by ensuring that management aligns expectations with actual process capabilities. Management should govern good data management by first setting realistic and achievable expectations for the true and current capabilities of a process, method, environment, personnel, technologies, etc.;

Management should continuously monitor process capabilities and allocate the necessary resources to ensure and enhance infrastructure, as required (for example, to continuously improve processes and methods; to ensure adequate design and maintenance of buildings, facilities, equipment and systems; to ensure adequate reliable power and water; to provide necessary training for personnel; to allocate the necessary resources to the oversight of contract sites and suppliers to ensure adequate quality standards are met, etc.). Active engagement by management in this manner remediates and reduces pressures and possible sources of error that may increase data integrity risks;

Adoption of a quality culture within the company that encourages personnel to be transparent in failures so that management has an accurate understanding of risks and can then provide the necessary resources to achieve expectations and data quality standards;

Mapping of data processes and application of modern quality risk management and sound scientific principles across the data life cycle;

Modernization of the understanding of all site personnel in the application of good documentation practices to ensure that the GxP principles of ALCOA are understood and applied to electronic data in the same manner that has historically been applied to paper records;

Implementation and confirmation during validation of computerized systems that all necessary controls for good documentation practices for electronic data are in place and that the probability of the occurrence of errors in the data is minimized;

Training of personnel who use computerized systems and review electronic data in basic understanding of how computerized systems work and how to efficiently review the electronic data and metadata, such as audit trails;

Definition and management of appropriate roles and responsibilities for quality agreements and contracts entered into by contract givers and contract acceptors, including the need for risk-based monitoring of data generated and managed by the contract acceptor on behalf of the contract giver;

Modernization of quality assurance inspection techniques and gathering of quality metrics to efficiently and effectively identify risks and opportunities to improve data processes.

To access the draft see: WHO

Posted by Dr. Tim Sandle

Tuesday 17 November 2015

World Antibiotic Awareness Week

World Antibiotic Awareness Week (16-20 November 2015) and the Antibiotic Guardian campaign. This is an annual event marked throughout Europe.

The objective for the 2015 Antibiotic Guardian campaign is for at least 100,000 healthcare professionals and members of the public to have committed to at least one pledge for prudent use of antibiotics on the Antibiotic Guardian website.

Pledge and post the following:

“I have pledged to be an #AntibioticGuardian. You can make a pledge too via

Antibiotic Guardian has been developed by Public Health England (PHE) in collaboration with Department of Health’s Expert Advisory Committee on Antimicrobial Resistance and Healthcare Associated Infections (ARHAI); the Department for Environment Food and Rural Affairs (DEFRA), the Devolved Administrations and professional bodies/ organisations towards the ‘One Health’ initiative.

Posted by Tim Sandle

Monday 16 November 2015

ESPAUR report reveals continued rise in antibiotic resistant infections

A new report from Public Health England (PHE) shows that overall antibiotic resistant infections increased through 2014. Rates of bloodstream infections caused by Escherichia coli and Klebsiella pneumoniae increased by 15.6% and 20.8% respectively, from 2010 to 2014. However, Streptococcus pneumoniae bloodstream infections reduced by 23% between 2010 and 2014, which may be related to increased pneumococcal vaccination rates.
ESPAUR is a programme developed by PHE to improve the surveillance of antibiotic resistance, antibiotic use data and support interventions and toolkits to improve antibiotic prescribing in general practice and hospitals. Each of these areas are key components of the UK cross-government Antimicrobial Resistance (AMR) Strategy.
Reducing the amount of antibiotics that are prescribed is vital in tackling resistance and today’s report shows that the number of prescriptions dispensed in primary care has declined for the second year in a row. Although the number of prescriptions issued has decreased, when measuring total antibiotic consumption in primary care, there has been an increase of 6.5% between 2011 and 2014, with 2.4% of the increase occurring between 2013 and 2014. This suggests that longer courses and/or higher doses of antibiotics are being prescribed in general practice.
Use of broad spectrum antibiotics (antibiotics that are effective against a wide range of bacteria and more likely to drive antibiotic resistance) has decreased in primary care to 8.5%. This decrease now means that England is the lowest prescriber of some of these drugs in the European Union.
Early evidence suggests that informing prescribers of their prescribing patterns and comparing them to their peers may help reduce antibiotic prescribing. These findings show that a continued focus by every individual who prescribes, administers and dispenses antibiotics is essential to continue to reduce antibiotic consumption.

Posted by Dr. Tim Sandle

European Sterile Products Guidance Under Review

Annex 1 to the EU GMP Guide is under review. The annex focuses on sterile products. To consider what might be expected, Tim Sandle has written an article for American Pharmaceutical Review assessing what the new version might contain and some personal reflections about what it should contain.

“Annex 1 to the European Union Good Manufacturing Practice (GMP) guidelines is now under formal revision, with a concept paper issued during February 2015 and with a view to implement the new document during 2016. Annex 1 is a key part of European GMP for it affects the production and filling of sterile products. The document is also of global importance as manufacturing centers importing into Europe need to comply with the guidance. In addition, previous versions of the Annex have proven to be influential on other international regulators.”

The reference is:

Sandle, T. (2015) European Sterile Products Guidance Under Review, American Pharmaceutical Review, September / October 2015: 1-4

For a copy, please contact Tim Sandle

Posted by Tim Sandle

Sunday 15 November 2015

A Primer on Disinfectants and Boosting Efficacy

Infection Control Today has issued a free report titled “A Primer on Disinfectants and Boosting Efficacy.”

The report presents a review of the basics relating to disinfectants and how to ensure their proper and optimal use in healthcare institutions as part of a structured program to address healthcare-associated infections.

In the report the following is considered:
  • What disinfectants are and what they are designed to do
  • The many factors that influence disinfectant efficacy
  • Boosting effectiveness of cleaning chemistries and avoiding contamination
The report is very U.S.-centric, and it only covers a narrow range of disinfectants. However, it is a fair introduction into the subject.

For details, see Infection Control Today

Posted by Tim Sandle

Saturday 14 November 2015

Sharps Safety: Advancing the Agenda to Curtail Injuries and Exposures

Experts say a greater commitment to safety is necessary to avoid occupational injuries and exposures. A special Digital Issue of Infection Control Today explores current rates of reported sharps-related injuries and blood/body fluid exposures; looks at recent data characterizing efforts toward improving safety, and presents the findings of a survey of infection preventionists.

See: Infection Control Today

Posted by Tim Sandle

Friday 13 November 2015

Pharmacopeial Forum 41 (5)

A new edition of the Pharmacopeial Forum has been issued.  This is volume 41, issue 5, which covers the period September – October 2015.

Highlights include:

Chapter 1 Injections and Implanted Drug Products (Parenterals) – Product Quality Tests
(Revision proposal target, USP39-NF34 2nd Supplement) - change to chapter name and update to text.

There are five USP general chapters that link with USP's taxonomy for pharmaceutical dosage forms: Injections and Implanted Drug Products 1, Oral Drug Products—Product Quality Tests 2, Topical and Transdermal Drug Products—Product Quality Tests 3, Mucosal Drug Products—Product Quality Tests 4, and Inhalation and Nasal Drug Products—General Information and Product Quality Tests 5. The five general chapters provide critical product quality attributes for the various dosage forms by the various routes of administration.

Chapter 1029 Good Documentation Guidelines
(Revision proposal target, USP39-NF34 2nd Supplement)

This proposed new general chapter provides guidelines on how to develop and maintain good documentation practices within Good Manufacturing Practice (GMP) operations.

Chapter 1228.3 Depyrogenation by Filtration
(Revision proposal target, USP39-NF34 2nd Supplement)
 This is an additional general chapter to the Depyrogenation 1228 family of chapters. This chapter provides an overview of depyrogenation by filtration and the various approaches and technologies used to complete it

Chapter 1228.5 Endotoxin Indicators for Depyrogenation [NEW]
(Revision proposal target, USP39-NF34 2nd Supplement)
 This is an additional general chapter to the Depyrogenation 1228 family of chapters. In this chapter the biological tool used to challenge the depyrogenating capabilities of a process will be defined as an endotoxin indicator. The following topics will be discussed in this chapter: endotoxin and lipopolysaccharide, applications of endotoxin indicators, preparation and use of endotoxin indicators, and analysis of test results.

Chapter 1229.13 Sterilization-in-place [NEW]
(Revision proposal target, USP39-NF34 2nd Supplement)
A new general chapter as an addition to the Sterilization of Compendial Articles 1229 family of chapters. This chapter discusses sterilization of a system or piece of process equipment in situ (sterilization-in-place; SIP) to reduce the need for post-sterilization handling. This chapter provides information on the common elements of the SIP process, different physical methods used for performing SIP, and routine process control

Chapter 1231 Water for Pharmaceutical Purposes
(Revision proposal target, USP39-NF34 2nd Supplement)

The following list includes a summary of the changes:

Updating the chapter to improve the organization and clarity of the information and remove redundant discussion text. This includes the organization into nine specific sections listed below.
Removing wording redundant to referenced monograph wording.
3Adding a detailed Outline/Table of Contents to improve user's topic discussion findability (topics will be hyperlinked in future electronic USP versions).

Significant revisions have been made or discussion added in several reorganized sections: 1. Introduction; 2. Source Water Considerations; 3. Waters Used for Pharmaceutical Manufacturing and Testing Purposes; 4. Validation and Qualification of Water Purification, Storage, and Distribution Systems; 5. Design and Operation of Purified Water and Water for Injection Systems; 6. Sampling; 8. Microbial Considerations; and 9. Alert and Action Levels and Specifications. The remaining section 7. Chemical Evaluations is not being revised at this time.

Posted by Dr. Tim Sandle

CACR new edition (cleanroom journal)

A new edition of Clean Air and Containment Review has been issued. In the new edition there will be articles on:
  • Airborne particle deposition in cleanrooms: Deposition mechanisms by W Whyte, K Agricola and M Derks
  • Product Oriented Contamination Control (POCC) by Koos Agricola
  • Importance of risk assessment for aseptic transfer in pharmaceutical compounding by Tim Sandle
  • Containment and Ebola in an outbreak setting by Allan Bennett, Simon Parks and Tom Pottage
  • EU GMP Annex 1 by Tim Eaton
The reference to the Tim Sandle article is:

Sandle, T. (2015) Importance of risk assessment for aseptic transfer in pharmaceutical compounding, Clean Air and Containment Review, Issue 23, pp10-16

 Posted by Tim Sandle

Thursday 12 November 2015

FDA revised guidance for analytical method validation – reviewed

Analytical method validation is an important requirement to support the package of information submitted to international regulatory agencies in support of new product marketing or clinical trials applications. Back in 1987, the US Food and Drug Administration (FDA) issued its first guidance on analytical methods. The document was subsequently revised in 2000 and, despite the advancement in analytical methods, there were no further updates until 2014, when a new draft was issued for public comment. Following the period of review, in July 2015, the FDA issued a new version of the guidance. The third edition is titled Analytical Procedures and Methods Validation for Drugs and Biologics.

A new article assesses the main points and the key changes in the document.

The reference is:

Sandle, T. (2015) FDA issues revised guidance for analytical method validation, GMP Review, 14 (3): 8-10

For a copy please contact Tim Sandle

Posted by Tim Sandle

Wednesday 11 November 2015

Structural aspects regarding surgical pathology of children

A new paper of interest:

“This study illustrates the structural aspects of processed pieces, prepared as microscopic preparations, after the appendectomy of children. For the study, information from cases that came to the emergency service, from the specialized hospitals for children from Braşov and surrounding counties, was used. With the study 12 cases of appendectomy diagnosed with gangrenous acute appendicitis, complicated by peritonitis, were selected. The patients were children from both from the urban and the rural environment. The children were admitted to the emergency service with acute symptomatalogy. The surgery pieces were analyzed using Hematoxilyn Eosin and Van Gieson stains, from samples taken after appendectomies, for the cases with the abovementioned pathologies. For comparison of the histopathology diagnosis, microscopic preparations, prepared with Gömöri Silver Impregnation stains of normal appendixes, were used.”

The paper has been written by Antonella Chesca, Tim Sandle, Dmitriy Babenko, and Ilya Azzov. The reference is:

Chesca, A., Sandle, T., Babenko, D. and Azzov, I. (2015) Structural aspects regarding surgical pathology of children, Annals of the Romanian Society for Cell Biology, 14 (9): 65-69 doi: 10.ANN/RSCB-2015-0024:RSCB

The paper can be accessed online here.

Posted by Tim Sandle

Tuesday 10 November 2015

Clinical Evidence Summary Antimicrobial Chemotherapy

Human papilloma virus (HPV) is the causative agent of cervical and anogenital cancers, with the HPV16 strain responsible for up to 60% of all HPV-associated cancers. Little is known about HPV susceptibility to disinfection. Researchers, using a novel method of virus production, demonstrate how two commonly used disinfectants are unable to inactivate HPV in a liquid suspension test.

For further details, see Infection Control Today

Posted by Tim Sandle

Monday 9 November 2015

Characterizing the Microbiota of a Pharmaceutical Water System

Bacterial populations inhabiting pharmaceutical grade water systems were investigated over a fifteen year period. The systems analyzed were mains water, purified and Water-for-Injection (WFI). Samples of water were tested by membrane filtration and the samples cultured using R2A agar. Culture based methods and phenotypic identification methods were used to characterize the isolates. The research was undertaken to produce an in-depth study of the microbiota of pharmaceutical grade water systems. The results presented act as a benchmark for industrial and pharmaceutical microbiologists to review comparable systems against, as well as to present a review of the typical culturable microorganisms recoverable from pharmaceutical water systems.

The above is an abstract of a new study which seeks to benchmark and characterise the typical microorganisms recovered from a pharmaceutical grade water system. The study appears as a peer reviewed paper, written by Tim Sandle.

The reference is:

Sandle, T. (2015) Characterizing the Microbiota of a Pharmaceutical Water System-A Metadata Study, SOJ Microbiology & Infectious Diseases, 3 (2): 1-8

For a copy, please contact Tim Sandle

Posted by Tim Sandle

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