E-Letters are topic-specific, electronic newsletters published four times per year by ISPE's global Communities of Practice (COPs). The content for E-Letters is submitted by professionals working in the pharmaceutical industry and is a resource by which to share best practices, regulatory news, technical articles and innovative solutions to real world problems.
A Forum for the Science of Exposure Assessment
The British Occupational Hygiene Society will host the 7th International Conference on the Science of Exposure Assessment (X2012) 2 – 5 July 2012 in Edinburgh, Scotland. The conference series provides leading experts a forum on exposure assessment sciences and has been influential in the development of this field, particularly, occupational exposure assessment. More.
Two-Part Series Focuses on Cleaning Validation for the 21st Century
2012 ISPE Tampa Conference to Explore Cost Effective, High Quality Facilities: Integrating Emerging Technologies
Increased reject, recalls, and manufacturing efficiencies may be attributed to a lack of understanding of the science and how engineering connects with quality product. The 2012 ISPE Tampa Conference (27-28 February 2012, Tampa, Florida, USA) will demonstrate how an engineer can turn science into high quality, low cost operations and product. The conference will also focus on available “new technologies” that can be applied today, and technologies that are emerging. Several tracks are in development, including a joint effort by the OSD and Containment Communities of Practice. More.
Containment Education at ISPE 2011 Annual Meeting
Containment COP Weighs in on FDA Guidance on Non-Penicillin Beta-Lactam Risk Assessment
ISPE submitted comments to the FDA on the agency’s “Guidance for Industry on Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework.” Comments were based on the Containment COP’s review of the Guidance. More ( 105 KB).
ISPE 2011 Annual Meeting Offers Training Course and Education Sessions Related to Containment
New Risk-MaPP Resources: Blog and FAQs
ISPE published the Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) in September 2010. The Guide provides a scientific risk-based approach, based on ICH Q9 Quality Risk Management, to manage the risk of cross contamination in order to achieve and maintain an appropriate balance between product quality and operator safety. The Guide has generated much discussion. In response to industry needs, ISPE has set up a blog and developed an FAQ document dedicated to the issues related to the Risk-MaPP Baseline Guide. More.
Containment COP to Form Subcommittees
The Containment COP Steering Committee would like to form subcommittees to work on Education, Affiliate/Chapter Relations, and Technical Documents. Interested in helping out? Contact Beth Brock at email@example.com.
FDA Releases Q&A on cGMPs for Penicillin
What is Penicillin? What are the Penicillin drugs? Is cross-contamination a concern with Penicillin drugs? Are their special manufacturing requirements for Penicillin drugs? The FDA answers these questions in a Q&A guidance document intended to represent the Agency’s current thinking on this topic. Read more.
Searching for the Next Hypalon
Glove manufacturers and suppliers are left wondering “What now?” after DuPont’s announcement of plans to close its sole producing Hypalon-brand plant in the US. Follow ISPE’s Containment COP on the trail to find alternatives for what has long been a polymer of choice for gloves in the pharmaceutical industry. Read more.
Are You Within REACH?
A white paper gives an update on the EU chemicals regulation called Registration, Evaluation, and Authorization of Chemicals (REACH) and how process manufacturers are dealing with this regulation since it came into force two years ago. The regulation requires businesses to register commercial use chemicals and their exposure to humans and the environment.
Patricia McDonnell is currently carrying out a PhD in Occupational Hygiene at the National University of Ireland, Galway (sponsored by GlaxoSmithKline). The aim of the research is to develop an exposure model for predicting exposures in the pharmaceutical industry focusing on the application of the Advanced REACH Tool (ART) exposure model to the pharmaceutical industry and investigating control measures applied therein. This will involve developing an inventory of control measures used within the industry and a classification system. The model will assign efficacy values to the control measures, which refer to their efficiency at reducing inhalation exposures (e.g. efficacy value of 0.1 is equivalent to a 90% reduction in personal exposure level). If you would feel able to advise Tricia with relevant data or where to find information sources specifically relating to: controls used within the industry and typical efficacy values at reducing exposure, please email her: firstname.lastname@example.org, or email@example.com.
Guidance on UK Local Exhaust Ventilation (LEV) Revised
The Health and Safety Executive (HSE), the main industrial safety regulatory body in the UK, has recently issued revised guidance on the specification, design, operation, maintenance, and inspection of LEV Systems. Read more ( 63 KB).
Reducing Cross Contamination Risks with Online TOC Measurement
Avoiding cross contamination from one batch to another is extremely important for GMP-compliant cleaning facilities. Transfer of active substance residues from production items of one filling line to another via the cleaning process can be prevented with online Total Organic Carbon (TOC) monitoring. Read more ( 14 KB).
Dry Powder Sampling and the Containment of Hazardous Compounds
This new Knowledge Brief by Jonathan Lind provides a high level review of the requirements for the successful containment of hazardous compounds associated with dry powder sampling activities. Read more.
What the Containment Community is Discussing Right Now
Decontamination showers, misting showers, and a growing trend toward fogging systems continue to be a hot topic of discussion on the Containment COP site. Read more.
Brazil’s ANVISA to Revise GMPs, Address Cross Contamination
Brazil’s National Health Surveillance Agency (ANVISA) is revising its Good Manufacturing Practices for Medications. Recently released, the revisions include a section on production practices for the prevention of bacterial and cross contamination. Read more ( 335 KB).
An article in Chemical & Engineering News by Ann M. Thayer looks at how synthesizing highly “potent” compounds is a lucrative and growing niche for custom chemical manufacturers. Read more.
History of Pharmaceutical Banding
An article in Chemistry Today by John Farris, Allan Ader, and Robert Ku discusses the history, implementation, and evolution of the pharmaceutical hazard categorization and control system. Read more.
Highlights from the 2009 Containment Technology Forum in Tampa
Excellent speakers and presentations. Good balance between IH and engineering data. The best containment session to date. Huge audience response. Good information on current topics in containment. Great sharing of information. Very good cross-section of industry solutions. These are just some of the comments from participants who attended the Containment Technology Forum 4 – 5 March 2009 as part of the ISPE Tampa Conference. Read more ( 78 KB).
What the Containment Community is Discussing Right Now
What is the limit for cleaning validation of product noncontact parts such as floors and walls? What are the precautions required while manufacturing steroids in liquid preparation where non-steroidal formulations are being manufactured? These and other questions are current hot topics under discussion on the Containment COP site. Read more.
Containment and OSD Event at Interphex NY a Success
ISPE’s Containment and Oral Solid Dosage (OSD) Communities of Practice (COPs) joined forces in an exclusive reception held 18 March at the Jacob Javits Center in New York, NY. More than 100 participants enjoyed a night of networking, an update on COP activities, and socializing thanks to the following sponsors: Bosch Packaging Technology, Bureau Veritas, Floura LLC, Integrated Containment Systems, Powder Systems/Chargepoint, and Safebridge Consultants.