A number of studies have demonstrated the incidence of cytotoxic surface contamination in pharmacy production units. Effective cleaning can be difficult but is essential to minimise contact exposure to pharmacy employees and guarantee product quality. This is now reflected in the joint publication from The Royal Pharmaceutical Society and the NHS Pharmaceutical Quality Assurance Committee.
“It is essential to ensure facilities and conditions are maintained…This is ensured by regular monitoring and testing of the environment…and forms an essential part of the quality assurance of all aseptically-prepared products.” (Chapter 11).
“Particular importance should be attached to obtaining meaningful results, monitoring trends, setting ‘in-house’ standards and action limits, investigating out-of-specification results and deviations and undertaking corrective and or preventative actions (CAPA). Information should be actively and knowledgeably assessed and not merely filed for record purposes.” (Chapter 11).
“The effectiveness of cleaning should be routinely demonstrated by review of the surface monitoring programme employed; both microbiological and chemical…” (Chapter 12).
“Surface monitoring for residues (in particular, hazardous materials such as cytotoxic agents) should be routinely undertaken (minimum annually) and trending carried out. The sites chosen for residue monitoring should reflect the perceived highest risk areas. Cleaning regimens should be demonstrated to effectively remove chemical contamination.” (Chapter 12).
Quality Assurance of Aseptic Preparation Services: Standards. Part A. Fifth Edition. Edited by Alison M Beaney D Prof, MSc, FRPharmS (2016).
BSTL’s monitoring service is designed, in part, to address these guidelines and provide the hospital pharmacist with a clear and comprehensive strategy to understanding its cleaning challenges and the means to generate scientifically robust, meaningful monitoring data with appropriate data processing techniques.
With more than 30 years experience working with cytotoxic drugs BSTL is well placed to advise on testing requirements. Dr Alan Wilkinson works closely with the Laboratory of the Health and Safety Executive as well as the National Institute for Safety and Health (NIOSH) in the US, both agencies being responsible for ensuring occupational health and safety. Professor Michael Allwood, author of “The Cytotoxics Handbook”, brings his expertise and insight to the design, execution and integration of state of the art monitoring assays and process activities both in pharmacy and on the ward.
We will work with you to understand your specific cleaning challenges and provide a bespoke solution with specific guidance on interventions to enhance cleaning efficacy and to support cleaning and training validations.
Critically, our approach provides a route of entry to rapidly establishing trending data for cleaning processes as required by the RPS/NHSPQAC, ensuring that your unit will be audit-ready and is able to demonstrate a commitment to the generation of meaningful data and a proactive approach. BSTL’s proprietary data processing and trending approach is integrated with all of our surface monitoring programs and analysis and follow-on actions for suggested improvements to existing cleaning procedures will also be provided.
With analysis packages available to best suit the task at hand, pricing and turnaround times are designed to provide the best value for money, on an appropriate time-scale.
No matter the application, the proprietary BSTL swab kit contains all you need to collect samples and return them to our laboratory for analysis by the latest LC-MS/MS methodologies. The swab sampling is very easy to perform, with high recovery rates, ultra-low (picogram) detection levels, with no need for cold chain storage or transportation throughout the workflow.
Contact us today to arrange a discussion of your needs and how we can bring maximum value to your monitoring activities.
Call our Business Support Team on 0330 111 4585
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