Guidelines raise standards for Contamination Control
Recent guidelines aimed at raising standards of contamination control in the pharmaceutical industry mean organisations need to assess their current practices, that’s according to Ecolab Life Sciences, a worldwide provider of market leading products and services for the control of microbial contamination in the cleanroom environment.
A number of the recent guidelines such as the PI 007-6 PIC/S (Pharmaceutical Inspection Co-operation Scheme) ‘Recommendation on the Validation of Aseptic Processes’, the draft revision to Chapter 5 “Production” of the EU Guide to GMP and the MHRA’S Questions and Answers for Specials Manufacturers, all represent a shift in regulatory expectations against which organisations should assess their current practices.
For example, PI 007-6 highlights the need to use sporicidal agents wherever possible, but particularly for ‘spraying in’ components and equipment to aseptic areas.
This change means that users should consider a sporicide for transfer disinfection, rather than the alcohol which is traditionally used, but is not sporicidal.
Ecolab Life Sciences already offers an appropriate sporicide through a choice of Premier Klercide-CR Sterile Biocides C and E.
Furthermore PI 007-6 PIC/S and the FDA Aseptic Processing Guide also state that the effectiveness of disinfectants and how they react on different surfaces should be validated.
However, the validation of disinfectant efficacy and time taken to achieve a satisfactory log reduction of the specific in-house organisms on the surfaces used in the manufacturing area places additional demand on internal resources and will require significant technical support.
It is a complex process, but the technical expertise of Ecolab Life Sciences’s Global Validation team makes it uniquely placed to support their customers and ensure it is carried out as stipulated.
Additionally, the draft revision to Chapter 5 “Production” of the EU Guide to GMP says the requirement to avoid contamination for all products through the appropriate design and operation of manufacturing facilities, implementation of operational and technical measures commensurate with the risks assessed and controlled through the principles of Quality Risk Management must be adopted.
One way to reduce the risk of contamination in critical product contact areas is with low residue disinfectants and especially with the use of endotoxin tested products.
Ecolab Life Sciences already offers a product range to minimise the impact of residues.
As part of its three step DDE cleanroom cleaning system, which when used correctly will Disinfect, Detect and Eliminate, the firm also provides a full programme to address this risk for the entire environment and reduce the likelihood of product contamination.
In the specific case of product contact areas, both the high grade wipes material and the solution used in them and applied to your surface are endotoxin tested, making them a highly efficient and powerful way to eliminate the risk of contamination in high risk areas.
Meanwhile, MHRA guidance on dispensing systems for disinfectants in cleanrooms states that they should prevent ‘suck back’, ensuring the integrity of the product is completely protected throughout its entire use and not simply at the manufacturing stage. In addition, PI 007-6 also highlights the requirement for disinfectants and detergents used in Grade A and B areas to be sterile at the time of use and not simply prior to use, as has previously been the case.
Both these requirements support Ecolab Life Sciences’s unique SteriShield Delivery System (SDS), the only validated trigger spray system on the market which creates a fully closed system, preventing air entering the bottle.
Research has proved that conventional trigger sprays used with cleanroom disinfectants do suck back air, meaning the contents of the bottle can be contaminated from the first moment of use, leading to a spread of contamination around the cleanroom.
The fully validated protected trigger spray operates as a closed system due to the vacuum created in use, with the dip tube providing the only point of exit from the bag of sterile liquid, which protects the sterility of the contents indefinitely, with a recommended best practice in-use shelf life of three months.
As well as these latest guidelines, Ecolab Life Sciences acknowledges that the risk is not restricted to the point of manufacture and can be further spread to any and all component parts of the process.
The draft revision to Chapter 5 “Production” of the EU Guide to GMP states that the quality requirements established by the manufacturer should be discussed and agreed with the suppliers. Appropriate aspects of the production and control, including handling, labelling, packaging and distribution requirements, complaints, recalls and rejection procedures should be documented in a quality agreement or specification.
For the first time, suppliers of starting materials must have fully audited processes in place which match those of their customers and that the level of supervision should be proportionate to the risks posed by the individual materials. This takes into account their source, the supply chain complexity, the final use to which the material is put in the medicinal product, as well as the manufacturing process.
Put simply, the quality of supplier and the manufacturing process is more critical than ever and customers need to ensure that suppliers are audited and validated, to provide the necessary level of assurance.
Ecolab Life Sciences is so confident that its own manufacturing processes match those of its customers, it has recently introduced the Process Match assurance mark, something which is unique in the market place.
James Tucker, Marketing Director at Ecolab Life Sciences says: ‘Our fully validated sterile product range for use in the cleanroom environment is manufactured in our own purpose built cleanroom, under conditions which match those of our customers, a fact highlighted by Process Match.
‘We also provide high levels of technical support, including product technical files, support for efficacy studies, as well as training and seminars.
‘As a business we understand the advantages and constraints of working to GMP and as such are the ideal partners for the supply of cleaning and disinfection products and the related equipment, to help both new and existing customers deliver contamination control without compromise.’
For more information email; InfoLS@ecolab.com or call +44 (0)2920 854 395.
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