Manufacturing

ISO Certified Manufacturing

4titude®'s manufacturing standards comply with DIN EN ISO 9001:2008 and ISO 13485:2012

Precision Tool Design

4titude®’s highly skilled engineers have extensive knowledge and experience in the design and manufacture of precision tools for injection moulding of thin walled and other laboratory consumables to tight tolerances. The latest technology is used for tool making, resulting in precision components of outstanding quality. Injection moulding tools undergo regular inspection and maintenance schedules to ensure that all parts are moulded consistently and to highest standards.

Cleanroom Injection Moulding - Class 7 ISO Certification

Our cleanroom production in the UK has achieved class 7 ISO certification which indicates a 10 fold lower amount of air particle compared to most PCR plate manufacturers. Class 7 cleanrooms are usually used for the production of biopharma products, sterile pharmaceuticals, medical devices and implants. This certification ensures the products remain free from particle contaminations such as bacterial and eukaryotic cells, dust or pyrogens.

Virgin, Medical Grade Polymers

4titude® uses medical grade and fully bio-compatible polymer granulates in all our processes. As an additional measure of bio-safety, we only work with virgin materials and avoid the use of mould release agents or other additives which may have a detrimental effect on product purity.

ISO Certified Manufacturing

4titude®’s manufacturing standards have complied with DIN EN ISO 9001 since 2009. In 2014, 4titude® achieved ISO 13485. To see the current ISO certificate, please click here.

This second accreditation is given to organisations that meet the requirements for a comprehensive quality management system for the design and manufacture of medical devices. It affects every aspect of the manufacturing process, with particular emphasis on risk management, change control and traceability throughout the supply chain. ISO 13485 is one of the strongest indicators of best quality and manufacturing practice.

Quality Control

4titude®'s plastic consumables undergo a wide range of QC inspections during and after the production process. We perform visual, physical and biological tests to ensure both the absence of contaminants, as well as the integrity of products at all times. Tests include:

100% Inspection

Using a proprietary electrical discharge detection method, every plate is tested for its well integrity. Due to the sensitivity of this test, 4titude® can guarantee the absence of pin holes and knit lines which could otherwise lead to loss of valuable samples during DNA amplification (PCR plates only).

Visual Inspection

All plate types are visually inspected for moulding defects, impurities and for batch to batch consistency. Using state of-the-art measuring equipment, we verify that all parts have been produced to our own published tolerances or to industry standard specifications where appropriate (e.g. according to SBS standards).

Biological Testing

We perform functional QC testing using quantitative PCR (qPCR) to ensure that all products are free from nucleases (DNases & RNases) as well as human genomic DNA. LAL-Assays are used to test raw materials and finished product for the presence of endotoxins.

PCR Performance Test

PCR Plate Samples undergo thermal cycling for leak testing under extreme temperature conditions. At the same time, plates are tested for sealing performance using heat seals, adhesive seals and cap strips.