Where did syphilis come from?

Did Columbus bring the disease syphilis back with him from the New World, or was it in Europe all along? Katherine Wright, winner of the Wellcome Trust science writing prize 2013, has investigated this issue in a fascinating article.

Here is an excerpt, all about the spread of Treponema pallidum:

"As its many names attest, contemporaries of the first spread of syphilis did not know where this disease had come from. Was it indeed the fault of the French? Was it God's punishment on earthly sinners?
Another school of thought, less xenophobic and less religious, soon gained traction. Columbus's historic voyage to the New World was in 1492. The Italian soldiers were noticing angry chancres on their genitals by 1494. What if Columbus had brought the disease back to Europe with him as an unwelcome stowaway aboard the Pinta or the Niña?"

To read the full article, see The Guardian.

Posted by Tim Sandle

New book: Sterility, Sterilisation and Sterility Assurance

A new book of interest has been published. The book is titled ‘Sterility, sterilisation and sterility assurance for pharmaceuticals: Technology, validation and current regulations’ and it has been written by Tim Sandle. The book has been published by Woodhead Biomedicine, an imprint of Elsevier.

The book addresses the following concerns:

• The main sterilisation methods of physical removal, physical alteration and inactivation.
•  Discussions relating to medical devices, aseptically filled products and terminally sterilised products.
• Bacterial, pyrogenic, and endotoxin risks to devices and products.
• The latest technology in the field.
• Current thinking behind risk assessment and good manufacturing practices. 

Throughout 18 chapters, the book outlines and discusses sterilization technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging and addresses the cleanroom environments in which products are prepared.

Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques.

The book is available directly from the publisher or via Amazon and other good booksellers (such as Waterstones and Powells).

The Amazon links are:

Amazon U.S.

Amazon U.K.

Amazon Canada

Amazon China

Amazon France

Amazon Germany

Amazon Austria

Amazon Italy

Amazon Spain

Amazon India

Amazon Japan

An e-book version is available from the publisher.

Tim Sandle is Head of Microbiology at the Bio Products Laboratory, Elstree, UK and a visiting tutor with the School of Pharmacy and Pharmaceutical Sciences, Manchester University, UK

Reference:

Sandle, T. (2013). Sterility, sterilisation and sterility assurance for pharmaceuticals: Technology, validation and current regulations, Woodhead Publishing, Oxford

Microbes can help solve murder mysteries

Studies on decomposing mice suggest that the microbial content of a corpse can offer clues as to how old a body is and the approximate time that death occurred.

From studies on dead and decaying mice, where the microorganisms were examined, researchers have been able to narrow down the times of death of mice to three-day windows. This is by identifying the microbes present in and on their bodies using DNA sequencing. This came from studies on 40 decomposing mice over 48 days.

Commenting on the study, Jessica Metcalf, a postdoc at the University of Colorado Boulder and an author of the study, told NPR’s All Things Considered that: "What we’re looking for is whether the microbial community changes in a clock-like manner." The answer was 'yes it does'.

To show this, researchers collected samples of archaea, microbial eukaryotes, and bacteria from their skin, from within their abdominal cavities, and from soils associated with each corpse. They found that the bacteria, particularly those from the order Rhizobiales, were especially useful for estimating time of death.

The team is now working to estimate time of death in humans using a similar approach. Currently researchers estimate time of death by looking at the development of blow fly larvae in corpses. The new research suggests that the microorganisms could present an equivalent method or even something more accurate.

The findings have been published in the journal eLife. The free-to-read paper is titled "A microbial clock provides an accurate estimate of the postmortem interval in a mouse model system."

Posted by Tim Sandle

Innovations in biosimilar product development

Total BioPharma have issued a new e-book of interest on biosimilars.

The potential benefits that biosimilars offer are well celebrated through providing improved patient access to affordable, effective and complex treatments. The demand for affordable treatments in the face of escalating healthcare costs is high but a number of hurdles present themselves when bringing a biosimilar from bench to market.

For further details, see Total BioPharma.

Posted by Tim Sandle

Screening for hospital pathogens

A new microfluidic device (for handling small volumes of fluids) has been developed by researchers to screen for hospital pathogens like Pseudomonas aeruginosa.

Pseudomonas aeruginosa is a bacterium common in soil and water; it has also been associated with hospital acquired infections. People with weakened immune systems are at a particular risk, especially from the disease cystic fibrosis (the forming thick layers of mucus in the lungs).

To help the diagnosis of the pathogen, MIT researchers have developed a new microfluidic device that could speed the monitoring of bacterial infections associated with cystic fibrosis and other diseases. The advantage with the device is that it can screen patient samples faster and with greater accuracy.

The microfluidic chip is etched with tiny channels, each resembling an elongated hourglass with a pinched midsection. Researchers injected bacteria through one end of each channel, and observed how bacterial cells travel from one end to the other. The cells were propelled by electrical forces. Depending on the type of bacterial cell, they either passed through the channel's narrow section or were trapped at the opening. By using this method, the researchers could screen which bacteria are pathogens and which are harmless.

To demonstrate the method, the researchers examined ordinary strains of P. aeruginosa, along with mutant strains that were missing certain genes required to make the dangerous pathogens. From their experiments, the researchers found that their device is able to distinguish benign bacterial cells from those that are more likely to be pathogenic.

The study was a collaboration between scientists at Ghent University, Belgium, and the University of Queensland, in Australia. The findings have been published in the journal PLOS One. The paper is called “Dielectrophoresis-Based Discrimination of Bacteria at the Strain Level Based on Their Surface Properties.”

Posted by Tim Sandle

New edition of the Pharmacopeial Forum

A new edition of the Pharmacopeial Forum has been issued. This is Volume 39, Number 6 (Nov– Dec 2013).

Items of interest include:
           
Chapter 7 - Labelling

(Revision proposal target, USP38-NF33)

The previous proposal in PF 38(1) was cancelled and a new proposal was published in PF 38(6). This new proposed general chapter provides definitions and standards for labelling of official articles. On the basis of comments received, this general chapter is being revised to include new provisions and edits to previously proposed revisions.

Chapter 1787 - Measurement of Sub visible Particulate Matter in Therapeutic Protein Injections [New proposed chapter]

(Revision proposal target, USP38-NF33)

Posted by Tim Sandle

Updates to United States Pharmacopeia

The 1st Supplement to USP36-NF31 has recently been issued. Updates of interest are:

Biological Tests and Assays

Chapter 87 - Biological Reactivity Tests. In Vitro

Changes to the following sections: Introduction, Cell Culture Preparation, Agar Diffusion Test, Direct Contact Test, and Elution Test

Chapter 88 - Biological Reactivity Tests, In Vivo

Changes to the following sections: Introduction, Classification of Plastics, Extracting Media, Systemic Injection Test, Intracutaneous Test, Implantation Test, and Safety Test—Biologicals.

Physical Tests and Determinations

Chapter 643 - Total Organic Carbon

Changes to: Introduction, Bulk Water and addition of Sterile Water section.

Chapter 645 - Water Conductivity

Changes to sample collection procedure for Sterile Water.

General Information



 Chapter 1031 - The Biocompatibility of Materials Used in Drug Containers, Medical Devices and Implants

Introduction; In Vitro Testing, In Vivo Testing, and Class Designation for Plastics and Other Polymers; Biocompatibility of Medical Devices and Implants; and Guidance in Selecting the Plastic or Other Polymer Class Designation for a Medical Device
           
Chapter 1118 - Monitoring Devices – Time, Temperature and Humidity

The general information chapter has been re-written and the devices described in this chapter are those most commonly used to monitor the controlled storage and established distribution of drug products following Good Distribution Practices (GDP).

In addition, some further sterilization chapters have been produced:

Chapter 1229 - Sterilisation of Compendial Articles [NEW]
Chapter 1229.1 - Steam Sterilisation by Direct Contact [NEW]
Chapter 1229.2 - Moist Heat Sterilisation of Aqueous Liquids [NEW]

There has also been an update to the chapter relating to water:

Chapter 1231 - Water for Pharmaceutical Purposes

Types of water, Chemical Considerations

The 2nd Supplement to USP36-NF31 is shortly to be issued. Items of interest here include:

Apparatus for Tests and Assays

Chapter 16 - Automated Methods of Analysis. This chapter has been deleted.

General Information


 Chapter 1030 - Biological Assay Chapters – Overview and Glossary [NEW]

Chapter 1034 - Analysis of Biological Assays - Appendix–Glossary, Glossary, and Glossary References added.

The USP–NF is a single–volume combination of two official compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). Monographs for drug substances and preparations are featured in the USP. Excipient monographs are in the NF.


Posted by Tim Sandle

Pathogen Safety: Would you like a free pass?

Dear Group Member,

In the run-up to the Pathogen Safety Summit taking place next week, this group has been offered the opportunity to participate in a competition to receive a free pass to the summit!

Please see their message below:

We understand that the constant evolution of pathogens threatening to overcome your biosafety strategies is a real challenge. How would you like a complimentary guest pass* to attend our upcoming PathogenSafety Summit in Munich on 18th - 20th November, to hear practical strategies to this from the experts?

Our partners have contributed towards 2 free passes to the summit, to enable you to join Heads of QA/QC, Process Development, Microbiologists and Viral Specialists from organisations including the FDA, Genzyme, CSL Behring, Merck-Millipore, ISIA and Rentschler Biotechnologie! They will be hearing unpublished research and in-depth case studies about how to:

   * KEEP CALM AND CARRY ON when your manufacturing facility reports contamination – interactive sessions with Synthon

   * Ensure quality when sourcing raw materials and replacing animal-derived media components – strategies from Genzyme and Cobra Biologics

   * Accelerate detection of Mycoplasma using rapid microbial methods and statistical tools – case study from MSD

   * Perform cell line viral risk assessments in harmony with EU Annex 2 and ICH Q5A – key insights from Novartis

   * Troubleshoot and discuss your challenges utilising new technologies with the FDA

And we don't want you to miss out! Entering our prize draw is simple - just email enquire@iqpc.co.uk with your details below:

Name:

Job Title:

Company:

Phone No.:

If you are unable to make it yourself, please do feel free to forward this opportunity to a colleague who may be interested!  For more information take a look at the agenda online.

I look forward to hearing from you very shortly.

Kind regards,

Jon Shah

Pathogen Safety Summit

T: +44 (0)20 7036 1305 | E: enquire@iqpc.co.uk | W: www.pathogensafetysummit.com

*Complimentary passes offered by IQPC are non-transferrable between organisations and only transferrable between individuals within the same organisation where written permission is obtained from IQPC in advance. Complimentary passes are available to Pathogen Safety Summit end-user companies only. The offer does not extend to any company whose main or partial business is the provision of products or services of any kind to the aforementioned company types. IQPC reserves the right to revoke or refuse issue of complimentary tickets at any time.

Posted by Jon Shah

Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods

PDA Technical Report 33, Revision 2013 (TR 33): Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods has now been issued.

Technical Report No. 33, Revision 2013 (TR 33):Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods is intended to provide guidance for the successful evaluation, validation, and implementation of alternative and rapid microbiological methods needed by the pharmaceutical, biotechnology and medical device industries to assure product quality.

For further details, see PDA

Posted by Tim Sandle

CRE: The new superbug?

Carbapenem-resistant Enterobacteriaceae (CRE) is a group of gram-negative bacteria, including Klebsiella species and Escherichia coli, that have high levels of resistance to carbapenem antibiotics.

On 7 March 2013, CNN reported:

“Hospitals need to take action against the spread of a deadly, antibiotic-resistant strain of bacteria, says the Centers for Disease Control and Prevention. The bacteria kill up to half of patients who are infected.

“The bacteria, called carbapenem-resistant Enterobacteriaceae or CRE, have increased over the past decade and grown resistant to even the most powerful antibiotics, according to the CDC. In the first half of 2012, 200 health care facilities treated patients infected with CRE.”

According to the CDC:

“Healthy people usually do not get CRE infections. In healthcare settings, CRE infections most commonly occur among patients who are receiving treatment for other conditions. Patients whose care requires devices like ventilators (breathing machines), urinary (bladder) catheters, or intravenous (vein) catheters, and patients who are taking long courses of certain antibiotics are most at risk for CRE infections.

“Some CRE bacteria have become resistant to most available antibiotics. Infections with these germs are very difficult to treat, and can be deadly—one report cites they can contribute to death in up to 50% of patients who become infected.”

Elsevier has some interesting references to CRE, which can be found here.
Posted by Tim Sandle

Consideration for infection control

Infection control is one of the most important aspects of healthcare and is based on the objectives of preventing transmission of infection between patients, and on the prevention of patients from contracting nosocomial infections (hospital acquired infections).

To explore the main routes of contamination and to explore some of the preventative measures that can be adopted, Tim Sandle and Jennifer Sandle have written a review article for Arab Medical Hygiene.

The article considers surfaces, equipment, clothing, flooring, staff screening, staff training, vaccination, good building design, infection surveillance, hand sanitisation, and cleaning and disinfection.

The reference is:

Sandle, T. and Sandle, J. (2013). An Important Aspect of Healthcare: Outlining the many considerations of infection control, Arab Medical Hygiene, October 2013, pp34-39

For a copy, please contact Tim Sandle

Posted by Tim Sandle

Clean Air and Containment Review

A new edition of Clean Air and Containment Review is available (issue 16). This excellent publication covers cleanrooms, controlled environments, clean air devices, and contamination.

The latest issue features the following articles:

• Control of floor level contamination by Gerry Prout
• Cleanroom lighting and LEDs by Graham Gould
• Biological indicators for hydrogen peroxide vapour technology by Lynne Murdoch
• Trends in healthcare cleanroom practice: single-use sterile disposable technology by Tim Sandle
• Conference report: GERPAC 2013 by Tim Coles

For details about subscribing, see CACR.

Posted by Tim Sandle

Bicontamination: New PHSS Technical Monograph

The PHSS (Pharmaceutical and Healthcare Sciences Society) have issued a monograph on biocontamination control: PHSS Technical Monograph No 20 (2013).

The monograph was put together by a team of healthcare and pharmaceutical professionals (Pharmaceutical Microbiology’s Tim Sandle was part of the team). The monograph has been reviewed by the U.K. regulatory inspection agency, the MHRA.

The contents are:

• Section 1. Introduction and scope includes a review of the challenges and requirements for Bio-contamination control and cross contamination control with a holistic approach to monitoring and proactive investigations in response to increased risk from changes in biocontamination profiles.
• Section 2. Bio-contamination characterisation and risk profiling. Methodologies and strategies that profile bio-contamination through establishing control, in operations and holistic monitoring.
• Section 3. Bio-contamination control principles and best practice guidance considering Quality by Design, different processes, control attributes, background environments and Barrier technologies.
• Section 4. Bio-contamination monitoring including classical and Rapid Micro Methods (RMM).
• Section 5. Bio-contamination Deviation management including considerations and guidance in completing investigations and undertaking corrective and preventative actions (CAPA).

For further details, see the PHSS

Posted by Tim Sandle

Key concerns for infection control

Clostridium difficile and norovirus appear to be the main causes of concern for infection control professionals as we enter the winter months according to the latest survey. Conducted at Infection Prevention 2013, the survey revealed that 48% of the respondents highlighted C difficile as the primary cause of concern and 36% highlighted norovirus.

Carried out by Bioquell, a provider of no-touch infection control solutions to the healthcare industry, the survey of 170 infection control nurses and senior practitioners were asked to rank various pathogens in order of priority and also indicate any others that they were concerned about. The findings revealed that CPE (carbapenemase-producing Enterobacteriaceae) was becoming a major concern (19%). Additionally, Acinetobacter (2%), MRSA (4%) and VRE (4%) were further potential issues being faced by infection control teams.

For more details, see Hospital Pharmacy Europe.

Posted by Tim Sandle

Pharmig: 21st Annual Microbiology Conference

Pharmig (Pharmaceutical Microbiology Interest Group), is hosting its 21st Annual Microbiology Conference. The event - the leading microbiology event for UK and Ireland - is taking place on 20th & 21st November, 2013.

The venue is the Oxford Belfry Hotel - Oxford.

The key speakers are:

• Di Morris, Pharmaceutical Solutions Ltd (ex MHRA)
• Andrew Matthews, Quantum Pharmaceuticals
• Barbara Gerten, Merck Millipore
• Michael Miller, Microbiology Consultants, LLC & Owner rapidmicromethods.com
• Edel Fitzmaurice, Fitzmaurice Scientifi c Ltd
• Julie Roberts, J. Roberts Associates Ltd
• Dr Anthony Hilton, Aston University
• John Hutcheson, Hutch20 Ltd
• Dr Simon Richards, MEDDEV QA Ltd
• Rachel Blount, Nitritex
• David Keen, GlaxoSmithKline
• Dr Tim Sandle, Bio Products Laboratory
• Tony Mayhall, Custom Pharmaceuticals
• Stephen McGrath, TEVA Pharmaceuticals Ireland
• Paul Newby, GlaxoSmithKline

For further details, see Pharmig.

Posted by Tim Sandle