Particle Measuring Systems offers specialised advisory services focused on contamination control, designed to assist with diverse operational challenges. The team are equipped with a wealth of background, education, and industry expertise and are able to provide guidance at every stage of a customers process. Whether it involves addressing non-compliance issues, establishing new policies, or training employees, the advisory services aim to navigate and enhance customers’ contamination control efforts.
The team engage in ongoing dialogue with global regulatory agencies, to ensure that customers stay informed about the latest requirements, aligning operations with industry standards. These two case studies spotlight specific instances where Particle Measuring Systems advisory services have played a pivotal role in resolving contamination control issues and illustrate the practical application and impact of the advisory service expertise in supporting customers across different scenarios.
Providing high-level expertise to meet compliance requirements to Manufacturer of next-generation vaccines
Challenge
The COVID-19 crisis has launched a manufacturer of next generation vaccines into the spotlight, transforming it from a company that was pioneering research into mRNA technology into a large-scale drug manufacturer that is mostly managed through Contract Manufacturing Organizations (CMOs). The company was inundated by the enormous amount of data generated by CMOs and requested by regulatory authorities, and they needed expert and specific knowledge about handling data and a large number of people.
PMS offer
Particle Measuring Systems (PMS) has been offering consultancy support on a global scale since 2019, and its team is comprised of pharmaceutical manufacturing process experts with direct experience in the field. The services offered by PMS contribute to
their positioning as a leader in contamination monitoring, ranging from sterility assurance and quality and control assurance to
improving production processes. In short, the PMS Advisory Team provides high-level expertise to help its customers meet compliance requirements.
Creating a customer-win situation.
The collaborative relationship between the vaccine manufacturer and PMS was born thanks to the team’s reputation, high professional level, and proven experience. Key personnel contacted the team directly to request urgent Quality and Control support to assess that critical phase. What started as an arrangement to support vaccine manufacturer for a few months subsequently became a collaboration started in 2022 that the customer renewed again this year.
How does this apply to other customers?
The successful experience with a global vaccine manufacturer in the spotlight demonstrates how a high level of competence and knowledge increases PMS’ reputation by building a solid bond of trust over time. More and more clients have requested consultancy services thanks to recently hired key people who introduced PMS because they have collaborated with us successfully in previous work experience and trust us.
Solving challenges and advising on best practices
Challenge PSM Pharma, a PMS customer, requested help on how to best install a particle counter in a cleanroom where they planned to manufacture aseptically filled injectables, which need the highest purity of air quality in the pharma industry for manufacturing. One of our international Advisors from the USA helped with this relatively easy task on short notice. During this consultancy, it became clear that the end customer had several further projects on which our Advisory group could assist.
About the customer
PSM Pharma is a contract manufacturer (CDMO) for pharmaceutical manufacturers around the world that offers aseptic fill &
finish as well as final packaging services for clinical and commercial phases. The company is a powerful partner that offers its customers comprehensive end-to-end customer support, maximum flexibility for different batch sizes, and top performance in the small to medium batch size range.
Benefits to the customer
The customer has access to the complete range of environmental monitoring knowledge of PMS. The advisory group was able to help with knowledge on particle transportation, risk assessments in rooms and machines, and microbial collection in water, in
air, and on surfaces. Even the data collection and the use of the data for trending later are being worked on by PMS personnel. The environmental monitoring specialists of PMS have helped to solve challenges, advised on best practices, and gave feedback on the process and the facility design. With up-to date knowledge of current regulations, PMS has helped PSM to build a state-of-the-art, world-leading, fill-finish facility.
“We have been using the services of the PMS advisory group over the past years and are working on several projects together at the moment. They have shown great expertise with environmental monitoring knowledge and are very helpful to us as an external consultant. The fact that the PMS advisory team knows about current regulations worldwide helps us build the best facility for all the needs of our customers.” Bianca Bohrer, CEO, PSM Pharma