The 20th anniversary Pharmig conference
Celebrating its 20th year of existence Pharmig, the UK organisation for pharmaceutical microbiology professionals, got to grips with future regulatory challenges and technical issues. One of the speakers, Dr Tim Sandle, provides highlights from the event
Wipe and disinfectant compatibility – 11-Jun-2013
The addition of a disinfectant to a wipe substrate may result in incompatibility issues, notably with chlorine-based disinfectants and quaternary ammonium compounds. When evaluating presaturated wipes it is crucial to ensure that efficacy testing has been carried out on fluid extracted from the wipe, otherwise the fabric could have an unknown detrimental effect on a disinfectant that worked perfectly well as a ready-to-use fluid
The selection of flooring – 7-Jun-2013
Cleanroom flooring systems must take account of the whole production process and materials must be chosen that will not give rise to airborne molecular or particle contamination. At the same time they must withstand harsh cleaning regimes and strong cleaning agents and disinfectants
Preserving reference cultures for QC and compliance – 5-Jun-2013
Reference cultures play an integral part in the procedures that are involved in effective cleaning, disinfection and environmental monitoring of production plants. One of the most important elements of maintaining any collection of reference cultures is ensuring the genetic stability of the strains within it; working cultures should therefore be no more than five generations removed from the original reference culture, and need a system for preserving and maintaining reference cultures with their original characteristics
Licensed to kill – 3-Jun-2013
Biocides have special approval rules rather that being regulated under the EU’s chemical control system REACH. The EU has decided safety assessments have to look not just at biocidal active ingredients and their combinations, but also at the finished products. The new regulatory procedure, which comes into force on 1 September 2013, is designed to take biocides with a damaging environmental impact off the market
Prepared for medical needs of tomorrow – 6-May-2013
The medical device market continues to grow, boosting demand for sterilisation services. The introduction of technically enhanced instruments has increased the need for advanced sterilisers that are compatible with such devices, marking a shift away from steam sterilisers to technologies such as ethylene oxide, vaporised hydrogen peroxide, hydrogen peroxide gas plasma, and ozone gas-based sterilisation
Raleigh Coatings has built a new bespoke cleanroom facility specifically for the production of silicone gel adhesive products for medical applications. It incorporates an integrated high clean preparation and production environment within a building that has been ergonomically designed using walls, fixtures and fittings to achieve clinical, contamination-free standards.
Breaking the chain of infection – 1-May-2013
A new type of germ transmission model which, in a first stage, tracks the transmission routes of micro-organisms in a public lavatory has been devised to assess the transmission of microbiological infection in healthcare environments by means of textiles. Various fibre variants have been examined, together with the importance of proper laundry procedures
Studies have shown a correlation between a cleaner patient environment, lower infection rates and reduced risk of transmission. A double-blinded randomised controlled trial conducted in two intensive care units by the University of Iowa showed that privacy curtains integrated with antimicrobial properties increased the time to first contamination compared with standard privacy curtains and reduced the bioburden.
Containment for cytotoxics – 10-Apr-2013
The increasing potency of active pharmaceutical ingredients is driving the requirement for more advanced containment systems to ensure operator safety at both pilot scale and for large-scale commercial production
A review process of the biocontamination control standard ISO14698 has begun. The standard is chiefly concerned with environmental monitoring, but has not been widely adopted because it is not mentioned in any GMP guidance, not does it offer details on how environmental monitoring should be undertaken. The comprehensive review should raise its profile.
Designing out contamination – 4-Apr-2013
Effective microbiological control is key to ensuring product safety, quality and image. In the event of a contamination incident the advice is to focus on looking for changes in raw material specs, equipment design failure, formulation or process error. While cleaning and sanitisation systems are crucial, preventative measures such as careful design of pipework and operation of supporting services, such as vacuum and vent systems, can radically reduce the risk of microbiological contamination
Catalent decided to undertake a fundamental redesign and improvement in the layout of its facility in Schorndorf to meet the latest standards, including a radical change to the air handling systems. The major project was planned and implemented with minimal disruption to the site's customer base
How to prevent drug shortages yet sustain quality – 1-Apr-2013
The US FDA reported that 251 drugs went into shortage during 2011, of which 73% were sterile injectables. The shortages followed a common pattern: one or more manufacturers temporarily stopped production to address a manufacturing quality problem, most often caused by microbial or particulate contamination. Sterility assurance, especially in facilities that are not fully automated, can be difficult to accomplish, but at the heart of the drug shortage problem is the inability of the market to observe, and therefore, to reward quality
Safe handling of animal pathogens – 6-Mar-2013
The Pirbright Institute’s new laboratory facility in Surrey will be one of the most advanced category 4 biocontainment facilities in the world. A fully functioning replica of the laboratory was built to ensure air leakage targets were met, with solid concrete rather than panellised construction and gaskets used to create airtight seals around every penetration of the structure.
Designing facilities for aseptic filling – 4-Mar-2013
China has implemented a new version of its Good Manufacturing Practice (GMP) standard, and has completely adopted EU GMP cleanliness standards and introduced the “in operation” classification. Annex 1, on the manufacture of sterile medicinal products, led to a new challenge, addressed by students in a project to design a hypothetical facility for the aseptic product of an antibiotic.
Air flow design: using the cascade approach – 8-Feb-2013
Differential pressurisation is frequently used as the mechanism to create segregated zones within a controlled environment, but maintaining accurate pressurisation in the face of leakage is a complex task. Careful design of a facility can make use of air flow to create a protective effect where no physical barrier is present
The way ahead for e-car assembly – 6-Feb-2013
Electric cars are viewed as a key technology for the future in Germany. Assembly lines with intelligent manual stations are the most efficient solution to meet the requirement for assembly to the highest standards of precision and cleanliness and to ensure and maintain maximum processing reliability for safety-critical components
Gas storage with no added pressures – 4-Feb-2013
Hazardous, toxic gases used in semiconductor fabrication are stored in and delivered from high-density media that adsorb gas molecules inside nano-sized pore structures, virtually eliminating accidental gas releases. ATMI’s BrightBlack precision nanoporous carbon has been specifically optimised for pore size and density to achieve the most favourable physical adsorption of these dangerous gas molecules.
Spacecraft are assembled in cleanrooms under the strict controls for bio-contamination as once sent into space the risk of biological contamination of other planets is high. Space agencies have defined standards by which to measure the bioburden and diversity of microbial species in the cleanrooms and on the spacecraft. The European Space Agency (ESA) is funding a collection of microbial strains from spaceflight hardware and associated assembly facilities at the DSMZ. This collection is an important resource for research institutes and industry to investigate adaptive mechanisms of bacteria (for instance, resistance to heat, UV radiation, ionizing radiation, desiccation, disinfectants).
Plasma cleaning goes under the microscope – 29-Jan-2013
Manufacturing at the scale required for nanotechnology demands pristine and controlled surfaces to create the desired structures, but maintaining this level of cleanliness over time may be difficult. Plasma technologies can be used to clean samples and microscopes, particularly of hydrocarbon molecules in electron microscopes.
The ins and outs of microbial monitoring – 4-Jan-2013
Routines for microbial monitoring of ambient air, surfaces and personnel in critical areas need to be as straightforward and fail-safe as possible to yield reliable results. Disposables, such as settle plates, contact plates and swabs, should thus be filled in cleanrooms that meet high microbiological standards. For testing irregular surfaces such as equipment recesses, nooks, crevices, tubing and filling needles, where contact plates are impractical, pre-moistened swabs may be used to validate cleaning and sanitation procedures and to verify that a required hygiene level has been reached.
Building better lab space – 11-Dec-2012
Laboratories are increasingly expensive to build and run. The S-Lab Conference and Awards held earlier this year showed how better power use and environmental performance are being achieved
Splitting the difference – 7-Dec-2012
Microfibre is the main material now used for cleanroom wipes for its ability to pick up and retain particle and for its high sorptive capacity. However, it is expensive and therefore not suitable for single use, but laundering mops and wipes carries a risk of degrading performance and cross-contamination.
Making the grade in filters – 5-Dec-2012
The removal of micro-organisms from fluids by passage through filters is a very complex process and is dependent on interactions relating to the chemistry and surface characteristics of the membrane, the micro-organisms, and the suspending fluid. The selection of a membrane filter for a particular product or process is an important choice and one that requires an assessment of the filter, the chemical nature of the product and the physical demands that will be placed on the filter.
Particulates in parenterals – 3-Dec-2012
Particulate matter is a key indicator of quality for injectable drug products. Test methods are being improved with the intent to find the materials responsible for the particle(s). The desired goal of zero defects is not a workable acceptance criterion for visible particulate matter because of current packaging components and processing capabilities. The value of vision inspection systems for elastomeric primary components is shown to mitigate the risk of particulates in finished parenteral drug products.