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What about quality, validation and documentation for single-use assemblies?

Strict quality assurance and full traceability at every step

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Quality plays a role in every step of the single-use assembly process

At Hitma, quality is paramount. Our single-use assemblies are assembled by our partner, UltraPure International. In their ISO Class 7 classified cleanrooms, the assemblies are assembled under a strict quality system that complies with the standards within the (bio)pharmaceutical, life science and biotech industries. With strict supervision of design, documentation, assembly, sterilisation and delivery, we guarantee the quality of the single-use assemblies.

Strict quality controls at every step

During and after assembly, the single-use assemblies undergo multiple quality checks.

Our single-use assemblies undergo:

Visual inspection of all components
Gross leak tests (optional)
And we can assist with performing laboratory tests, such as bioburden, USP <85> and USP <788>.

How do we guarantee traceability and change control of (complex) assemblies?

Each single-use assembly is linked to a unique batch code and is fully traceable down to component level. Even after months, we can reproduce the same configuration, including the validation file.

A change to the single-use product you purchase from us may affect your end product. Naturally, you need to be aware of the impact that changes may have on, for example, quality, specifications, packaging, labels or the certificate, the production process and the supply chain. If a component needs to be replaced, you will always receive a notification and we will assess whether additional validation is required.

Do the single-use assemblies come with audit-proof documentation?

Upon delivery of the single-use assemblies, you will receive all necessary documentation to comply with audit and quality control requirements. This documentation assists in complying with guidelines and regulations from, for example, the FDA and EMA. With each delivery, you will receive:

Certificate of Conformance (CoC)
Certificate of Analysis (CoA)
Batch records and component lists
IQ/OQ/PQ requirements (optional)
Extractables/leachables test results (optional)
Sterilisation validation and certification (optional)
Complete validation dossier (optional)

Lees verder over maatwerk single-use assemblies

What are single-use assemblies for processes in (bio)pharmaceuticals, biotech and life sciences?

How do we create the perfect customised single-use assembly for your process?

What is the process for a single-use assembly: from request to delivery?

How can standardisation assist you with scaling up and stock management?

Getting started with single-use assemblies

Are you curious about the most suitable single-use assembly for your process? View our range of standard assemblies or contact us using the form below to find the perfect customised assembly.

Want to know more about single-use assemblies for your specific process?

We are happy to help you. Please submit your question using the form below. We will contact you as soon as possible. Would you prefer direct contact? Please call us on 0297-514714.