ISO recertification of Bachem’s St. Helens site in the UK

February 16th, 2024

  • Bachem UK site successfully recertified to ISO13485 until 2027
  • ISO13485 is the international standard for quality management in the medical device industry and ensures high-quality, safe, and compliant medical devices.
  • Partnering with an ISO-certified CDMO offers many advantages.

ISO 13485 is an international standard that specifies the requirements for a quality management system in the medical device industry. This standard applies specifically to medical devices and covers the entire lifecycle of a product, from design and development to production, installation, and maintenance. It aims to ensure that medical devices are safe and effective for their intended use. In the peptide CDMO industry, ISO 13485-certification sets Bachem apart from other suppliers of raw materials for use in medical devices.
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The benefits of partnering with an ISO-certified CDMO

Working with an ISO-certified CDMO such as Bachem offers many advantages for customers, partners and, ultimately, patients:

 

  • Product quality assurance: Emphasis on quality management throughout the product lifecycle.
  • Regulatory Compliance: Adapting to the regulatory requirements of the medical device industry.
  • Traceability and documentation: Comprehensive documentation and traceability of processes, materials, and components throughout the supply chain.
  • Risk Management: A robust risk management system must be in place.
  • Consistency: Customers can expect consistent manufacturing processes.
  • Continuous innovation: At Bachem, we live a culture of continuous improvement. Organizations certified to this standard are committed to regularly reviewing and improving their processes.

Bachem’s Center of Excellence for Custom Synthesis

Acquired in 1999, the St. Helens site is our center of excellence for manufacturing research chemicals. The site uses state-of-the-art automated equipment and can efficiently produce over 1000 peptides per year in quantities ranging from milligrams to grams, supporting customers in the in-vitro diagnostic (IVD) field with both products and a full range of related services.

Bachem St. Helens, Bachem UK, BUK, ISO13485
Peptides or peptide mixtures are used in IVD to measure the presence or concentration of a biomarker molecule that indicates disease. They must meet the laboratory’s expectations to ensure the sensitivity and specificity of the test. It is essential to have a reliable and trusted source of quality peptides. To meet the requirements of the IVD industry, robust manufacturing processes, traceability, and reporting of critical change control for commercial supply must be implemented. We are proud that our site in St Helens, UK, has been re-certified to manufacture peptides as a critical raw material for medical devices.
Our continued compliance with ISO 13485 is key to our customer’s success in the highly regulated healthcare environment. This standard not only safeguards our established quality management system but also demonstrates our commitment to regulatory requirements, customer satisfaction, and the highest quality and safety standards. I want to emphasize the importance of the ISO 13485 re-certification for the Bachem St Helens site; we are proud to be re-certified and to continue our support to the IVD industry.
Iain Pritchard

Site Manager, Bachem St. Helens

Understanding your needs to support you in all phases of your projects

With many years of experience of the ISO13485 medical device standard and certification to date, Bachem is ideally positioned to understand the needs of our customers in the manufacture of their IVD kits and to assist in all phases of the project.

Delivering life-saving diagnostics

Join forces with the world’s leading peptide manufacturer for in vitro diagnostics – to help identify and treat serious medical conditions.
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