Rapid investigative contaminant support

 

It pays to be prepared - in the fast-paced world of pharmaceutical manufacturing unforeseen challenges can arise at any stage of the process. At RSSL we understand the critical need for prompt and reliable support, especially during emergencies. 

 

Leveraging our advanced analytical equipment and expertise, we offer expert consultation and testing services including specialised emergency services to provide in-depth analysis and examination of various components crucial to pharmaceutical product safety and quality.

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+44 (0)118 918 4000
lifesciencesales@rssl.com
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Support across every phase

 

During the preclinical and clinical phases of pharmaceutical development, packaging and the scale up manufacturing process play a crucial role in ensuring product safety, stability, and efficacy. Even with strict processes and packaging regulations adhered to, various challenges can arise, leading to potential contamination issues that must be addressed promptly and effectively.

 

This phase of drug development is identified to have an increased risk of contamination so knowing the potential contaminants and assessing risk is imperative in reducing this risk and ensuring quality assurance. Our team specialise in identifying and resolving issues to support the successful progression of your pharmaceutical products through these critical stages. With over 30 years’ experience and a wealth of contaminant data, we are perfectly positioned to deliver a service which is bespoke to the manufacturing process and your product. 

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We utilise advanced technologies such as confocal Raman microscopy, subvisible compendial methods and SEM with Cryo capability to conduct thorough analyses of not only contaminant materials but also materials which the product will come into contact with, including bags, syringes, containers and vials.

 

Using a combination of analytical techniques to gather comprehensive data on the materials' properties, we can determine the composition, structure, and elemental composition of each component with precision. Our investigations adhere to rigorous quality standards, conducted in accordance with RSSL's GMP quality system and are documented thoroughly, ensuring compliance with regulatory requirements. 

By examining the materials which will come into contact with the product for baseline particulate loads, we can rapidly identify and help safeguard the integrity of your products and ensure patient safety. This is carried out through the creation of a comprehensive database of component materials used in the manufacturing of the finished product, enabling rapid identification of any issues that may arise.

 

The quick detection and identification is crucial when foreign particulates are identified in patient specific products. Our team is available to provide out of hours, emergency support, ensuring timely and accurate responses to emergency and regulatory enquiries.  

Planned and tailored testing

 

The service is not just an emergency response, clients can also utlilise the service to carry out procedural preparation and testing. RSSL has the expertise to provide preventative recommendations through analytical testing of contact materials and on-site visits using our hand-held XRF for large metal objects which are too bulky to transport. This helps prevents future contamination issues and provides rapid identification which may arise.  We continue to support our clients through the postmarket phase by monitoring product performance and addressing any emerging safety concerns promptly.


At RSSL, we're not just about analysing particles; we're about empowering you with actionable insights. We can provide information regarding particle trends we observe and reports can be request on demand. With our bespoke library, you're not just getting data; you're getting tailored intelligence designed to meet your specific needs

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    Procedure preparation

    Consultation to assist with procedure preparation and testing, ensuring compliance with regulatory requirements and providing preventative recommendations. 

  • Scientists At An SEM

    Material Testing and Analysis

    Thorough analyses of materials which may come into contact with the product during the production process, including bags, syringes, containers, vials to determine baseline particulate loads and identify any potential issues. Using subvisible compendial methods and advanced techniques like confocal Raman microscopy, we can precisely identify particles and contaminants.

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    Database Creation

    Bespoke chemical and elemental databases documenting the components used in finished products, facilitating traceability and future investigations. These databases serve as a valuable resource for future reference and analysis which can be invaluable for rapid trend analysis and regulatory compliance.

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    Emergency Support

    Our team is on call to provide emergency support, including out of hours submissions, ensuring timely and accurate responses. Our emergency services are available when you need them most including support with regulatory submissions. 

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