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.


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