Wednesday, 30 April 2014

Hepatitis C Virus Infectious for Six Weeks on Surfaces?

According Lance's Science Macrocosm, A group of researchers from the Yale Schools of Medicine and Public Health demonstrated that hepatitis C virus (HCV) can remain infectious for up to six weeks on surfaces at room temperature. Previously, it was thought that HCV could survive for up to four days on surfaces outside the body, this new research extends that number by a month and a half.

The implications of these findings are far reaching, including safety of patients and workers in healthcare settings, as well as reducing viral hepatitis transmission associated with drug use.

The study, which was funded by the National Institute on Drug Abuse (NIDA), and was designed to assess the risk of HCV transmission after infectious material dried on environmental surfaces.

Posted by Tim Sandle

Pharmig news #55

A new edition of the Pharmaceutical Microbiology Interest Group (Pharmig) newsletter has been issued. In the new edition are:
  • The nature and environmental impact of control floor level contamination by Gerry Prout
  • Latest regulatory and industry news, compiled by Tim Sandle
  • Review of preserving cosmetics by Susan Birks
And more…

To obtain a copy, please contact: Pharmig

Posted by Tim Sandle

Tuesday, 29 April 2014

Pharmacopeial Forum Update 40 (2)

The USP Pharmacopeial Forum has been updated. In the new issue 40 (2), the following changes will be of interest.

Chapter 1083  Good Distribution Practices (Revision proposal target, USP38-NF33 1st Supplement)

A new series of informational chapters describing various aspects of the pharmaceutical supply chain replaces that which appeared as an In-Process Revision in PF 38(2) but since then has been cancelled. USP is proposing this new series of Good Distribution Practices (GDP) general chapters, which were developed based on a review of two existing general chapters, Good Storage and Distribution Practices for Drug Products <1079> and Good Distribution Practices for Bulk Pharmaceutical Excipients <1197>, and the previously proposed general chapter Good Distribution Practices—Supply Chain Integrity <1083>. The new general chapters will cover material flow beginning with initial procurement and continuing throughout the supply chain to delivery to the end user for pharmaceutical components and products, medical devices, and dietary supplements. The chapters will address four main GDP topics—Quality Management System <1083.1>, Environmental Conditions Management <1083.2>, Good Importation and Exportation Practices <1083.3>, and Supply Chain Integrity and Security <1083.4>—highlighting best practices and principles.

Chapter 1083.1 Quality Management System (Revision proposal target, USP38-NF33 1st Supplement)

Chapter 1083.2 Environmental Conditions Management (Revision proposal target, USP38-NF33 1st Supplement)


Chapter 1083.3 Good Importation and Exportation Practices (Revision proposal target, USP38-NF33 1st Supplement)

Chapter 1083.4 Supply Chain Integrity and Security (Revision proposal target, USP38-NF33 1st Supplement)

Chapter 1228 Depyrogenation (Revision proposal target, USP38-NF33 1st Supplement)

As part of the revisions to USP general information chapter Sterilization and Sterility Assurance of Compendial Articles <1211> and the genesis of the <1229> series of chapters, the USP Microbiology Expert Committee decided to separate information on sterilization from depyrogenation. This new chapter provides an overview of depyrogenation and introduces different means of depyrogenation and factors to consider in the selection of an appropriate method, validation of a depyrogenation method, and routine depyrogenation process control.

Chapter 1229.11 Vapour Phase Sterilisation (Revision proposal target, USP38-NF33 1st Supplement)

The USP has proposed separating current general information chapter Sterilization and Sterility Assurance of Compendial Articles <1211> into several individual chapters [see the Stimuli article entitled “An Outline of Planned Changes to USP <1229> Sterilization and Sterility Assurance of Compendial Articles” in PF 38(2)]. Vapour sterilization systems are well suited for surface sterilization of heat sensitive materials. This chapter will provide an overview of vapour phase sterilization and its validation.

Posted by Tim Sandle

Monday, 28 April 2014

Microbe World interviews Tim Sandle about #microbiology

MicrobeWorld explores the world of microbes with vivid images and descriptions. The magazine recently interviewed Tim Sandle about his career, inspirations and the latest developments in microbiology.

Here is an excerpt:

Q) Moving little ahead of your work. You have an experience of pharmaceutical microbiology risk assessment and investigation. Will you please elaborate your work as a risk investigator? How much you feel that risk investigation in the microbiological field is important in this modern world?

Tim Sandle: Risk assessment is of great importance and it is one of the key developments with pharmaceuticals in the past decade. In the past, the focus was on quality control and the idea of simply testing products and environments. This either meant that there was an attempt to 'test into compliance' or that the wrong things were being tested for. The approach also failed to consider how to stop risks from re-occurring.

The new risk management approach is more proactive. It involves looking at processes and considering where microbial contamination is likely to occur. Following this, the severity of the risk is considered, in relation to the environment and to patient harm. Attempts are then made to eliminate or to mitigate the risk. Only after all this has been completed is the monitoring plan decided, and here the objective of the plan is to see how effective the risk mitigation measures have been.

Applying risk assessment involves using tools like HACCP (Hazard Analysis Critical Control Points), which requires the process to be mapped; and FMEA (Failure Modes and Effects Analysis), which is particularly useful for equipment. For example, if you are concerned about the operation of an autoclave and its ability to effectively sterilize an item then FMEA can be a powerful tool.

Aside from machinery and environments, risk assessment is useful for considering the microbial risk to medicines. Where microorganisms are detected, knowing the species, the numbers and the toxins each helps to consider the risk to the patient. There is a body of work around the subject of Quantitative Microbiological Risk Assessment (QMRA), which is very useful. QMRA is the process of estimating the risk from exposure to microorganisms by combining dose response information for the infectious agent with information on the distribution of exposures.

There are four very distinct steps in the risk assessment process. The first step is hazard identification, which involves the collection, organization, and evaluation of all information pertaining to a pathogen or a nutrient. Second is hazard characterization, which determines the relationship between a pathogen and any adverse effects. Third is exposure assessment, which involves determining how much of pathogen might be ingested in a serving of food. The fourth, and last step, is risk characterization, which involves evaluating the risk and related information.

The interview can be accessed here: MicrobeWorld

Posted by Tim Sandle

Revision to EU GMP Annex 15: Qualification and Validation

EU GMP Annex 15, which relates to the important area of qualification and validation, is being revised. Tim Sandle has undertaken an analysis of the chapter and this has been reported to the current edition of Clean Air and Containment Review (CACR).

CACR is an indispensable guide to cleanrooms and clean air technologies, edited by John Neiger. The current issue also features article on gaseous decontamination of clean air devices, a review of diffuser performance in cleanrooms, a history of isolator and containment technology Part 1: Early containment leading to flexible film isolators, and carbon dioxide based solutions for cleanroom garment.


For further details about the current issue, please CACR.

Tim Sandle’s reference is:

Sandle, T. (2014) Revision to EU GMP Annex 15: Qualification and Validation, Clean Air and Containment Review, Issue 18, pp22-23

Posted by Tim Sandle

Sunday, 27 April 2014

Antimicrobial resistance

The ability of bacteria to evolve in response to pressure from antibiotics has been recognized since the discovery of penicillin. In less than a century, a complex array of factors has led to the emergence of bacteria that no longer respond to any approved antibiotics. Numerous recent calls to action have highlighted the urgent need to respond to this growing global health threat with improved surveillance and infection control, more judicious use of antibiotics, new prevention measures, and new therapeutic strategies to combat resistant bacteria.

Bacteria can acquire resistance through mutation or through horizontal transfer of genetic information. Resistant members of a population that are exposed to the selective pressure of antibacterial drugs will be amplified, which can ultimately result in treatment failures in the clinic. Resistance genes are ancient (even pre-dating human beings) and ubiquitous, and some of the most worrisome resistance genes have been found in diverse environmental samples, including drinking water. Furthermore, many bacterial species harboring resistance genes can colonize the human gut, skin, and other niches, where they serve as a ready source of infection when host defenses are breached. These bacteria can also serve as a source of AR genes for transfer to other bacteria, facilitating the interspecies spread of resistance.

AR is a complex and multifaceted problem that is driven by many factors, including:
  • Bacterial population density in health care facilities, which allows transfer of bacteria within a community and enables resistance to emerge;
  • Inadequate adherence to proven hospital hygiene measures;
  • An increasing number of high risk populations, including chemotherapy, dialysis, and transplant patients as well as those in long-term care facilities;
  • Overuse of antibiotics in agriculture;
  • Global travel and trade, which can lead to transfer of resistant infections and resistance genes;
  • Poor sanitation in certain areas, which can contaminate water systems and spread resistant bacteria in sewage;
  • Inappropriate use of antibiotics in human medicine (e.g., for viral infections);
  • Overprescribing of broad-spectrum drugs, which can exert selective pressure on commensal bacteria and predispose to secondary infection; and
  • Lack of rapid diagnostics to help guide appropriate use of antibiotics.
Antimicrobial resistance has become a global crisis. In the U.S. alone, drug-resistant infections cause roughly 23,000 deaths a year, and the supply of new antibiotics has dwindled. In a commentary in JAMA this week, NIAID Director Anthony S. Fauci, M.D., along with colleague Hilary D. Marston, M.D., M.P.H., examine the problem and highlight how NIAID has recently adjusted its antimicrobial research efforts to apply innovative approaches to basic, clinical and translational research to address the problem.

To read the JAMA commentary, see JAMA

Posted by Tim Sandle

Saturday, 26 April 2014

Microbiome Influences


Researchers find that gender, education level, and breastfeeding can affect humans’ commensal microbial communities.

The human microbiome is essential to health, and its disruption can lead to disease. Now, using data from the Human Microbiome Project (HMP), which has sampled the microbial communities of 300 healthy people at 18 body sites and analyzed additional samples from the same individuals, Patrick Schloss and Tao Ding of the University of Michigan have found that specific life-history events—namely, gender, education, and whether a person was breastfed as an infant—affected the composition of the body’s microbiomes as an adult. They published their results last week (April 16) in Nature.

Interestingly, by tracking microbiome makeup over the course of 18 months, the authors also found that the oral microbial community was the most liable, while those of the vagina and gut stayed relatively stable. Future research should aim to reveal changes over shorter time intervals.
Posted by Tim Sandle

Trimethoprim

In less-developed countries, inexpensive and well-tolerated antibiotics for therapy of streptococcal infections are often not available. Scientists have discovered that trimethoprim may provide an option. Bacteria are not generally resistant to this agent. In a new publication scientists demonstrated three pathways for the development of resistance -- meaning that streptococci can easily become resistant to the antibiotic and pass on this trait quickly.

Trimethoprim inhibits an enzyme of folic acid metabolism called dihydrofolate reductase, which plays an important role in bacterial growth. Trimethoprim thus prevents bacteria from proliferating in the body.

A new study shows that the antibiotic trimethoprim is a therapeutic option for Streptococcus pyogenes infections in some geographical regions of the world.

For further details, see:

R. Bergmann, M. van der Linden, G. S. Chhatwal, D. P. Nitsche-Schmitz. Factors That Cause Trimethoprim Resistance in Streptococcus pyogenes. Antimicrobial Agents and Chemotherapy, 2014; 58 (4): 2281 DOI: 10.1128/AAC.02282-13

 Posted by Tim Sandle

Friday, 25 April 2014

Engineering bacteria to act as sensors

Synthetic biologists programmed Escherichia coli to sense and record environmental stimuli, such as the antibiotic anhydrotetracycline, in the mouse gastrointestinal tract. This way, E. coli can be engineered into living diagnostics capable of non-destructively probing the mammalian gut.

The research has been published in PNAS, in a paper titled "Programmable bacteria detect and record an environmental signal in the mammalian gut".
Posted by Tim Sandle

Thursday, 24 April 2014

New USP Pharmacopeial Forum 40 (1)

Some proposed USP changes in the new edition of the USP Pharmacopeial Forum of interest to laboratory staff are:

Chapter 41     Balances (Interim Revision 1 July 2014)

Comments received indicate the potential existence of a problem with the repeatability requirement. When following the procedure as written in the chapter, the use of a large test weight may produce an unintended passing result. In order to correct this problem, the EC proposes to modify the test using the “desired smallest net weight” value as the divisor. The desired smallest net weight can be selected on the basis of the weighing operations performed in that particular balance.

Chapter 852   Atomic Absorption Spectroscopy [NEW] (Revision proposal target, USP38-NF33)


Accuracy and Precision requirements are revised, and other minor corrections are also incorporated.

Chapter 853   Flourescence Spectroscopy [NEW] (Revision proposal target, USP38-NF33)

Additional changes in the section Accuracy in Validation and Verification. The revision clarifies that the acceptance criteria apply to the mean value obtained.

Chapter 854   Mid-Infrared spectroscopy [NEW] (Revision proposal target, USP38-NF33)

Changes are proposed for this new general test chapter. In Wavenumber Accuracy, additional peaks of the polystyrene spectrum are mentioned. In Procedure, the microscope sampling technique is reinstated. In Accuracy in Validation and Verification, the acceptance criteria has been clarified to apply to the mean value obtained. Other minor corrections are also incorporated.

Chapter 857   Ultraviolet-Visible Spectroscopy [NEW] (Revision proposal target, USP38-NF33)

Several changes are proposed in this new general chapter. Under Qualification of UV–Vis Spectrophotometers, the acceptance criteria for Control of Wavelengths are revised. Clarifications are introduced in the Limit of Stray Light test. Accuracy requirements are revised to indicate that the acceptance criteria apply to the mean value obtained. Other minor corrections are also incorporated.

Chapter 1852 Atomic Absorption Spectroscopy – Theory and Practice [NEW] (Revision proposal target, USP38-NF33)

Additional changes are proposed for this new general information chapter.

Chapter 1853 Flourescence Spectroscopy – Theory and practice [NEW] (Revision proposal target, USP37-NF32)

Additional changes are proposed for this new general information chapter.

Chapter 1854 Mid-Infrared Spectroscopy – Theory and Practice [NEW] (Revision proposal target, USP38-NF33)

Additional changes are proposed for this new general information chapter

Posted by Tim Sandle

Wednesday, 23 April 2014

The Rapid Microbiology Lab: Applying New Technologies to Traditional Methods

“The Rapid Microbiology Lab: Applying New Technologies to Traditional Methods” and includes speakers from our company, Lonza and Charles River.

The event is from 10am to 5pm at the Plum Park Hotel (Watling Street, Towcester, Northants NN12 6LG) and includes lunch.

Agenda

1000 – Arrival, coffee, Tea, Pastries

1015 – Introductions

1030 – The Rapid Microbiology Lab, the role of automation and technology

1100 – Automating the Incubation, Detection, and Enumeration steps without changing sample preparation

1130 – Applying Automation to Sterility Testing

1200 – Lunch

1300 – Applying automation to Environmental Monitoring and Bioburden testing

1345 – The role of technology in Microbial ID

1445 – Creating the paperless lab

1545 – Break

1600 – Validation of automated technologies

1630 – The Importance of Support

1700 – Final Q&A, Departure

For details, see: RapidMicroBio

Posted by Tim Sandle

EU GMP Annex 15 Revisions: Improving Qualification and Validation

Annex 15 of the EU GMP guide is concerned with the ‘Qualification and Validation’ of pharmaceutical facilities, addressing requirements for equipment, utilities and processes that are used for the manufacture of medicinal products. The broad requirement of Annex 15 is that a pharma manufacturer needs to identify what qualification and validation work is required; next, the manufacturer must prove that critical aspects of work are controlled; and finally, the key elements of qualification and validation need to be defined and documented.

Validation and qualification form an important part of the quality system in the pharmaceutical sector and can be defined in different ways. Tim Sandle, Head of Microbiology, BPL, UK discusses some standard definitions from a Good Manufacturing Practice (GMP) perspective.

The article has been published in the current edition of Cleanroom Technology.

The reference is:

Sandle, T. (2014) EU GMP Annex 15 Revisions: Improving Qualification and Validation, Cleanroom Technology, April 2014, pp14-16

If you are interested in reading the article, please contact Tim Sandle

Posted by Tim Sandle

Tuesday, 22 April 2014

FDA reduces GMP inspection rate

The U.S. Food and Drug Administration (FDA) has announced that it is scaling back the number of routine quality inspections it plans to conduct in the U.S. each year by 40 percent. Instead the FDA will undertake more inspections overseas.


The change has taken place because of FDA concerns with imported medications. The FDA plans to conduct 591 good manufacturing practice (GMP) inspections in fiscal 2014 and 2015 in the U.S. This is down from the 967 performed during 2013-2014. In place, the FDA is aiming to perform 30 percent more foreign GMP inspections, conducting 843 inspections each year. Companies will be chosen for inspection based on the agency’s risk-based inspection model that grants leeway to high-quality companies.

Source: Pharmaceutical Manufacturing

Posted by Tim Sandle

Monday, 21 April 2014

Fungal contamination of pharmaceutical products


The second most common reason for the recall of pharmaceutical products is fungal contamination. To assess current trends and to evaluate risks, Tim Sandle has written an article for the European Pharmaceutical Review.

Most reports relating to the contamination of pharmaceutical products centre on bacterial contamination rather than fungi. The reasons for this may relate to few 'microbiology' laboratories in pharmaceutical organisations having trained mycologists; to an underestimation of the association between fungi and product contamination incidents; and due to a lack of appreciation of the risks that fungi can pose to cleanrooms and controlled environments. This article considers some of these issues and, in doing so, argues that the contamination risk posed by fungi to pharmaceutical products is greater than the level of industrial and academic interest would suggest.

The reference for the article is:

Sandle, T. (2014) Fungal contamination of pharmaceutical products: the growing menace, European Pharmaceutical Review, 19 (1): 68-71

For further details, please contact Tim Sandle

Posted by Tim Sandle

Pharmeuropa 26.2 (April 2014)

A new edition of Pharmeuropa has been issued. Pharmeuropa is a free online EDQM publication.Draft monographs are published in Pharmeuropa for public enquiry, which lasts for three months. Comments received are processed by EDQM, at this stage the draft can be amended and republished. 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.

Items of interest in the current edition are:


2.6.15 Prekallikrein Activator

Additional clarification provided on spiking experiments and high blank values.

2.5.32  Water: Micro Determination

The main changes in the proposed revision are the following:

the recommendation to determine quantities of water greater than 100µg has been included;
a suitable certified reference material may be used for instrument performance verification;
increased flexibility for the frequency of the verification of accuracy

2.2.20  Potentiometric titration

General method updated to introduce modern autotitrator instruments. Based on EU regulation 847/2012, reference to mercury-containing electrodes have been deleted

Sodium Hydroxide (0677)

The current manufacturing process for producing sodium hydroxide that complies with the current monograph will be changed by 2016 for ecological reasons. Due to the new process, the concentrations of chlorides and sulfates in the substance will increase and will no longer comply with the current limits. It is proposed to anticipate this situation and expand the limits of the tests concerned as this has no impact on the quality of the substance.

Posted by Tim Sandle

Sunday, 20 April 2014

Alconox Guide To Critical Cleaning


Alconox have issued a guide for cleaning within pharmaceutical facilities. This is a method-by-method review of critical cleaning procedures. Following, are specific examples of applications for detergents in healthcare, pharmaceuticals, laboratories, electronics, precision manufacturing, environmental sampling, and food and dairy processing.

To access the guide, go to: Alconox

Posted by Tim Sandle

Saturday, 19 April 2014

Inflammasomes: keeping the gut microbiota in check

Resident gut bacteria are important for digesting food, synthesizing nutrients, and controlling growth of pathogenic bacteria. Alterations in the gut microbiota can result in outgrowth of pathogenic organisms. Certain phyla of bacteria, namely Prevotellaceae and members of the TM7 phylum, elicit inflammation and have been associated with periodontal and inflammatory bowel disease (IBD).

This is the basis of an article by Elana Ehrlich and the article is being hosted by Qiagen.

Recently, mice deficient in the protein NLRP6 were shown to have a more colitogenic bacterial population with high representation of members of the Prevotellaceae and TM7 phyla. This colitogenic microbiota was transferable to neonatal and co-housed adult wild type mice. The altered microbiota stimulated CCL5 secretion which triggered chronic inflammation and increased incidence of spontaneous and induced IBD. NLRP proteins are components of inflammasomes, suggesting that NLRP6 inflammasomes are important for maintaining a healthy gut microbiota. These findings have implications for development of new treatment options for IBD. Analyzing inflammasome and related pathways such as autophagy, ER stress and innate and adaptive immunity, through real time PCR will expand our understanding of this process.

The full article can be accessed here: Qiagen

Posted by Tim Sandle

Friday, 18 April 2014

Directory of US Biotechnology Companies

The USA Directory of Biotechnology Companies 2014 is a comprehensive Excel Directory of companies and executives in the biotechnology industry. It contains contact information for more than 1,300 biotechnology companies.

This directory aims to keeps people informed about the thousands of personnel changes taking place due to company mergers, acquisitions, consolidations, and staff turnover.

For more information please click here.

Posted by Tim Sandle

Thursday, 17 April 2014

Tackling antimicrobial resistance


The looming disaster of antimicrobial resistance is a well-known one, but what is European strategy for tackling this ‘catastrophic threat’?  In an article for Laboratory News Tim Sandle examines the strategy and discusses the key implications.The link for the article is located below.

Antibiotic resistance more typically occurs when a sub-population of a microorganism survive the treatment of a bacterial population with an antimicrobial. Here as the sub-population regenerates, resistance is transferred to newly formed clones. It is an increasing problem, especially in the hospital setting.

The European Union has drawn up a strategy to slow-down the rate of antibiotic resistance. This strategy is dissected in the article, along with the global implications of the antibiotic resistance threat. The article can be accessed, for free, on-line here: Lab News.

The reference is:


Sandle, T. (2014) Taking on the resistance, Laboratory News, March 2014, pp20-21

Posted by Tim Sandle

Wednesday, 16 April 2014

Radiation resistant E. coli

Scientists have coaxed the model bacterium Escherichia coli to resist ionizing radiation and, in the process, reveal the genetic mechanisms that make the feat possible. The study provides evidence that just a handful of genetic mutations give E. coli the capacity to withstand doses of radiation.

The findings are important because they have implications for better understanding how organisms can resist radiation damage to cells and repair damaged DNA.

For further details, refer to the following paper:

R. T. Byrne, A. J. Klingele, E. L. Cabot, W. S. Schackwitz, J. A. Martin, J. Martin, Z. Wang, E. A. Wood, C. Pennacchio, L. A. Pennacchio, N. T. Perna, J. R. Battista, M. M. Cox. Evolution of extreme resistance to ionizing radiation via genetic adaptation of DNA repair. eLife, 2014; 3 (0): e01322 DOI: 10.7554/eLife.01322

Posted by Tim Sandle

Tuesday, 15 April 2014

International Biomedical Laboratory Science Day

Today is International Biomedical Laboratory Science Day.

International Federation of Biomedical Laboratory Science (formerly known as IAMLT) established BLS Day in 1996 at the World Congress in Oslo, Norway to promote and celebrate the key role of Biomedical Laboratory personnel in diagnostic and preventive health care systems.

The purpose with the BLS Day is to increase the awareness of the role that Biomedical Laboratory Scientists have in providing health care. BLS' play an important role in diagnosis, quality development and assurance, treatment, research, development, and public health care.

International BLS Day gives our profession a day to promote and celebrate ourselves as a profession.

The theme is selected by the International Body (IFBLS) related with health issues and support the WHO Millennium Development Goals.

BLS Day is the day for Laboratory personnel to promote awareness of our profession and the key role played by Biomedical Laboratory Scientists in the diagnosis and treatment of patients and research in the modern medical sciences.

For more details, see IFBLS.

Posted by Tim Sandle

Laboratory disinfectants: an introduction


The use of disinfectants in microbiology laboratories plays an important part in keeping areas under control and reducing levels of contamination. Tim Sandle has written an article for Lab World Magazine in which the best criteria for disinfectants are outlined.

The abstract reads:

“The quality control in microbiology investigations largely depends on control of source of contamination. The cleaning process, the cleaning, detergent and disinfection agents used in laboratories has been found to be major contributors of contamination. The article focuses on key concepts for selection and use of cleaning, detergent, disinfectants, sanitiser and antiseptic materials.”

For details, see Lab World Magazine

The reference is:

Sandle, T. (2014) Selection of Laboratory Disinfectants, Lab World Magazine, 3 (2): 17-22

For a copy of the article, please contact Tim Sandle

Posted by Tim Sandle

Monday, 14 April 2014

New Process Validation Guideline (EMA)

The European Medicines Agency has published the following concept paper ‘Guideline on process validation for finished products -information and data to be provided in regulatory submissions’.

Process validation can be defined as documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes. Continuous process verification has been introduced to cover an alternative approach to process validation based on a continuous monitoring of manufacturing performance. These concepts form the basis of the new guideline.

The guideline is brought into line with ICH Q8, Q9 and Q10 documents and the possibility to use continuous process verification in addition to, or instead of, traditional process validation described in the previous guideline has been added and is encouraged. This guideline does not introduce new requirements on medicinal products already authorised and on the market, but clarifies how companies can take advantage of the new possibilities given when applying enhanced process understanding coupled with risk management tools under an efficient quality system as described by ICH Q8, Q9 and Q10.

The EMA paper can be accessed here.

Posted by Tim Sandle

Sunday, 13 April 2014

Tips for Maximising Microscope Usage

Keyence have produced some interesting graphics relating to the use and care of microscopes.

The aim is to explore:
  • Concerns regarding the feasibility of effectively using the microscope once introduced
  • Concerns regarding the possible effect demonstrated by a digital microscope
  • The desire to improve the efficiency of analysis operations
  • The desire to capture clear, magnified images as targeted

For more details see: Keyence

Posted by Tim Sandle

Saturday, 12 April 2014

Cleanroom HVAC innovation


Heating, ventilation and air conditioning (HVAC) specialist, E-CO, has launched a product that could help cleanrooms and medical laboratories free of bacteria, viruses and other pathogens.

The stand-alone disinfectant product can be installed and fitted flush to the ceilings of individual rooms. It shines ultraviolet (UV) light on surfaces, sterilising them and reducing the spread of pathogens, such as MRSA and Clostridium difficile. E-CO says the UV light penetrates the cell walls of micro-organisms, damaging the DNA and preventing their ability to replicate.

The unit is automatically activated and cleanrooms and labs are equipped with motion and contact detectors to ensure doors are closed and rooms unoccupied when the UVC lights are operating. The units can also disinfect cleanrooms and labs overnight.

UVC technology has long been proven to kill bacteria, viruses and fungal pathogens. Hillary Spicer, Founder and Director of E-CO, said: “UVC technology has long been proven to kill bacteria, viruses and fungal pathogens and is effectively used in many US healthcare environments. We are delighted to be able to offer our UK customers this product. It is cost effective and simple to install but keeps surfaces free of contaminants. I’d like to see disinfectant technology like this used in every in cleanroom.”

Source: Cleanroom Tech

Posted by Tim Sandle

Friday, 11 April 2014

Regulation concerning the making available on the market and use of biocidal products


The EU directive covering the safe use of biocides and disinfectants was updated late year. The reference is: ‘Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products Text with EEA relevance’.

The CDC Handbook - A Guide to Cleaning and Disinfecting Clean Rooms

Biocidal products are necessary for the control of organisms that are harmful to human or animal health and for the control of organisms that cause damage to natural or manufactured materials. However, biocidal products can pose risks to humans, animals and the environment due to their intrinsic properties and associated use patterns.

The objective of the new Regulation is to improve the functioning of the internal market in biocidal products whilst ensuring a high level of environmental and human health protection. The new Regulation will also remedy a number of weaknesses that were identified during the 11 years of implementation of the current Directive 98/8/EC.

The purpose of this Regulation is to improve the free movement of biocidal products within the Union while ensuring a high level of protection of both human and animal health and the environment. Particular attention should be paid to the protection of vulnerable groups, such as pregnant women and children.

The new text simplifies and streamlines the requirements for approving active substances and authorizing products. The new provisions will also reduce animal testing by making data sharing compulsory and encouraging a more flexible and intelligent approach to testing. A dedicated IT platform (the Register for Biocidal Products) will be used for submitting applications as well as recording decisions and disseminating information to the public. The new Regulation is also the first piece of legislation to build in the new Commission definition on nanomaterials.

For further details see: EU directive

Posted by Tim Sandle

Thursday, 10 April 2014

FDA guidance: chemistry, manufacturing, and controls (CMC)

FDA released guidance providing recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes to be documented in annual reports. The guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that FDA has determined will likely have a minimal potential to have an adverse effect on product quality. FDA, therefore, states that applicants should document these changes in an annual report.

A list of examples of CMC postapproval manufacturing changes previously submitted under manufacturing supplements is provided that FDA has determined to be of low risk to product quality. The guidance also provides examples of minor changes to be documented in an annual report that were previously published in FDA’s Scale-up and Postapproval Changes (SUPAC) guidance documents and other postapproval change CMC guidance documents.

See: FDA

Posted by Tim Sandle

Wednesday, 9 April 2014

Ancient Giant Virus Discovered

A new species of giant virus discovered in the Siberian permafrost, where it’s been buried for 30,000 years, is reincarnated in the lab.

In PNAS of a new species of virus has been found by researchers at Aix-Marseille University in France discovered buried in the permafrost of Siberia.

The new virus, dubbed Pithovirus sibericum, measures 1.5 μm in length and 0.5 μm in diameter—even bigger than former record holders, the pandoraviruses, which are only 1 μm long and 0.5 μm in diameter. P. sibericum was identified as part of a survey of the virome of Siberian permafrost, isolated from a sample that’s more than 30,000 years old, according to the researchers. Nevertheless, when given access to an amoeba host in the lab, P. sibericum infected the cell, raising concerns about the possible risk such giant viruses might pose if they are released from the thawing Arctic ground.

The discovery also calls into question the veracity of some viral eradications, including smallpox and the livestock disease rinderpest.

Posted by Tim Sandle