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Our long-standing commitment to quality

With the constant pressure to do more with less, you need solutions that deliver precision and efficiency at every step of your forensic workflow. That’s why we’ve been deeply committed, for more than 20 years, to manufacturing human identification (HID) products that meet the highest industry standards—so you can get the answers you trust. 

It’s all about empowering confident analysis through our advanced manufacturing processes, proven Applied Biosystems™ solutions, and expert support services.

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Featured video: ISO 18385 and Beyond: We’re Serious About Quality

Thermo Fisher Scientific is proud to announce that our manufacturing facilities are ISO 18385–compliant. Take a tour of our Warrington, UK site, and see how state-of-the-art robotics and proven processes are setting a high industry standard for manufacturing of forensics products, and learn more about our commitment to providing quality forensics solutions.

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“At Thermo Fisher Scientific, we have actively participated in the development of the ISO 18385 standard and ensured compliance across our manufacturing lines in order to continue to deliver the highest-quality products for forensic testing.” —Lisa Calandro
Director of HID Professional Services, Thermo Fisher Scientific
Member of the ISO 18385 US Technical Advisory Group


ISO 18385: Raising the Bar

As a trusted leader among suppliers of products for forensic analyses, we are focused on providing our customers with products that meet the highest standards in the industry. That’s why we contributed to the creation of ISO 18385, collaborating with forensic practitioners and industry experts to define the new manufacturing standard that enhances the quality of HID products across the industry. 

“ “Our decision to raise the bar and comply with the ISO 18385 standard is in line with our heritage of providing high-quality tools that enable forensic labs to trust their results when they use our products. ” — Rosy Lee
Vice President and General Manager of HID
Thermo Fisher Scientific

What is ISO 18385?

ISO 18385 is a standard that addresses growing concerns within the forensic industry regarding the potential presence of low-level human DNA in consumables. The guidelines are intended to minimize the risk of human DNA contamination in products used to collect, store, and analyze biologic material, as well as providing policies by which to assess products prior to release.

To meet ISO 18385, manufacturers must:

  • Have a quality management system in place
  • Have a staff contamination detection provision 
  • Manage the risk of human DNA contamination by performing risk assessments for potential human DNA contamination and implementation of risk mitigations 
  • Have validated cleaning and environmental monitoring procedures
  • Apply post-production treatment to products (if possible), using a validated treatment process that does not negatively affect performance
  • Batch-release, with validated test methods, products that cannot be treated in post-production, and test for human DNA contamination by STR, qPCR, or any other equally sensitive, validated method
Manufacturers who fulfill the aforementioned requirements can label their HID products as “ISO 18385 Forensic DNA Grade”. 

Bringing you ISO 18385 Forensic DNA Grade products

Our HID solutions are manufactured at our location in Warrington, UK, a facility that meets the guidelines for ISO 18385 certification. As part of our long-standing commitment to the continual adoption of new methods that help ensure high-quality manufacturing, we have made significant investments across all aspects of production to minimize human DNA contamination. The result: powerful forensic DNA–grade solutions that enable you to provide answers with certainty and confidence. 

Our Warrington, UK facility

Our state-of-the-art Warrington, UK facility produces solutions that empower precise, confident analysis. From employees to equipment, we strive to bring you best-in-class quality in every aspect of our business. 

Our experienced personnel
You can count on every individual who works at our Warrington branch to provide expertise and experience.

  • We actively recruit personnel with a strong background in the life sciences.
    The majority of our staff have a minimum of a university degree in forensics or other life science–related discipline, and many have worked directly in forensic laboratories, enabling a full understanding of the requirements of the work being performed.
  • We require all employees to complete a detailed, intensive training program.
    We’ve developed a training matrix for each product and instrument at our facility. All operators are required to complete the training and pass an intensive competency review.  
  • We have ISO accredited auditors both on and off site. 
    We have employees within the organization who are accredited auditors to ISO 17025, ISO 13485, and ISO 9001. This level of accreditation enables them to assist in the assessment of ISO 18385. Additionally, we hire external, independent assessors to review our quality management system.

Our proven process
Our manufacturing workflow is specifically designed to minimize exposure to human DNA. Here’s how we minimize contamination in our solutions to enable reliable answers: 

  • We feature a one-way personnel flow process in our manufacturing facility.
    Operators move from areas with less potential for human DNA contamination to environments where the possibility for contamination is higher, but never in the opposite direction in the same working day.
  • We require full gowning where open product is present.
    Head-to-toe gowning helps reduce the potential of human DNA contamination.
  • We listen to feedback.
    We regularly consult with Field Application Specialists to refine our manufacturing capabilities. Customers also have the opportunity to review our operations, processes, and product designs.

Our cutting-edge facilities
We’re constantly working to create better ways to deliver high-quality HID products. Here are just some of the advanced features you can expect from our facility: 

  • Our filling operations are entirely automated.
    Our products never come into contact with human hands during the filling process. As a result, they are made clean and kept clean. 
  • We have dedicated HID and amplicon (allelic ladder) facilities. 
    Our Warrington site features dedicated facilities for HID products and amplicon production. Our amplicon facility is located 3 miles away from our HID facility. Operators who visit the amplicon facility cannot return to our HID facility on the same day, which helps reduce the risk of cross-contamination.  
  • We constantly monitor our manufacturing environment. 
    We monitor our Warrington manufacturing environment for the presence of any extraneous DNA to help ensure that our manufacturing process and our HID products remain human DNA–free. The monitoring of the facilities is performed through our validated monitoring and testing processes.

“My assessment has shown that there is a good correlation between the production of consumables at the Thermo Fisher Scientific sites in Warrington and the requirements stipulated in the standard ISO 18385.” —Kevin Sullivan
PhD, Director at Principal Forensic Services

Quality ensured

Products go through extensive quality control testing at every stage of production. We test raw materials through finished products to help ensure they are human DNA–free and meet the needs of our forensic customers. They are made clean and kept clean throughout the entire manufacturing process.  

1
Formulate
2
Fill
Quality control
Passed
3
Pack
Quality control
Passed
Finished goods
Quality control
Passed

Warrington in numbers

Site type: Manufacturing & distribution
Years of experience: 15 years of clean PCR product manufacturing 

Regulatory status:

ISO 9001: 1998
ISO 13485: 2010
OHSAS 18001:2007
ISO 18385: 2016 

Service description:
We manufacture and distribute consumables for life science applications. 

Features & capabilities: 

  • Quality management system
  • Full gowning
  • One-way flow
  • Elimination database
  • Fully automated filling
  • Validated cleaning process
  • PPI business system

Products manufactured include: labeled and unlabeled oligos, assays, PDARS, probes, sequence detection kits, Applied Biosystems™ PrepFiler™, STR, and Quantifiler™ kits, food and environmental kits, pharmaceutical QA/QC kits, and protein sequencing reagents.