Good Manufacturing Practice
28 November 2022
GMP principles are a foundation for the manufacture of plastic injection moulded components for the healthcare and medical device sector.
Ensuring products are of consistent high quality.
Good Manufacturing Practices (GMP) are minimum requirements, to ensure that products are created in a framework, which ensures they are of consistent quality and safe for their intended use. Although not GMP accredited, Tex Plastics work to the 10 principles of Good Manufacturing Practices. This is because we recognise GMP helps ensure the quality of design, monitoring, and control of both our manufacturing processes and facilities. Focusing on the following 5 P’s of GMP helps comply with strict standards throughout the entire production process. Our plastic injection moulded components are used in a wide variety of healthcare and medical device markets, including disposables, diagnostic components, surgical instruments, implants and orthopedics.
Plastic injection moulding for the healthcare and medical device sectors
With in-house design, prototyping, tooling and production facilities, we have demonstrated the skills and knowledge in our team, to help develop new and better products. Working closely with product designers, technicians, engineers and other innovators in the medical device and healthcare sector. Our Barnstaple facility has all the essentials for medical plastic injection moulded component manufacture. With extensive white room moulding and a fully validated EN14644 class 7 (10,000) cleanroom manufacturing cell, our facilities and accreditations enable us to effectively develop and manufacture medical devices, components and packaging.
10 Principles of Good Manufacturing Practices
- Create Standard Operating Procedures (SOPs)
- Enforce / Implement SOPs and work instructions
- Document procedures and processes
- Validate the effectiveness of SOPs
- Design and use working systems
- Maintain systems, facilities, and equipment
- Develop job competence of workers
- Prevent contamination through cleanliness
- Prioritise quality and integrate into workflow
- Conduct GMP audits regularly
ISO 13485:201
Our full ISO 13485:2016 accreditation in December 2022 will allow us to deliver even more high quality components for the healthcare and medical device markets. Extending the range and work we already do in the development of projects, including prototyping and validation services. This includes the creation of validation protocols and procedures (i.e. FAT, SAT, IQ, OQ, PQ, etc.), Gauge Repeatability and Reproducibility (GR&R) and Design of Experiments (DoE). Tex Plastics also develop component and device test methods for subsequent use in both validation and on-going production.
Medical, pharmaceutical and electronics market
Providing solutions for the technically challenging medical, pharmaceutical and electronics market sectors means understanding costs of entry. Which is why Tex Plastics have developed a unique product development capability. Our comprehensive “concept to completion” project solution for all conventional, white room and clean room thermoplastic requirements helps innovators bring their products to market.
This is a collaborative process working with the client’s product design team to review the qualities needed in the finished plastic component. This is then worked through the mould design, materials selection, manufacturing process and any finishing and assembly requirements. It results in a more robust and ‘fit for purpose’ component with minimal waste, which is manufactured in the most efficient way.
A Class 7 clean room manufacturing cell for injection moulding and component assembly of non-sterile medical products is combined with an extensive white room moulding area which services many different market sectors. Meticulous project management of comprehensive tooling validation protocols including Scientific Moulding disciplines ensures that our customers know Tex Plastics assures technical capability and a competitive edge with a clean room production facility operating at maximum efficiency.