Medical Injection Moulding Cleanroom - ISO 14644 | Plastech
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Medical Injection Moulding Cleanroom

Plastech has over 50 years of experience in the design and manufacture of injection moulded components for the medical device industry — and we are constantly improving the technology and processes that allow us to supply sound plastic solutions in this way. This includes our medical injection moulding cleanroom.

Our injection moulding machines are situated within a class 7 cleanroom and designed for manufacturing small to medium components. We have four laminar flow cabinets within the cleanroom for assembly requirements and our cleanrooms are built to carefully control the concentration of particles in the air and have ISO certification.

As a medical plastics solution, our cleanroom enables us to deliver precision injection moulding services for medical applicationsPlastech has been serving the medical device and pharmaceutical sector for over 30 years using our state of the art cleanroom facilities.

Contact us today to order your medical devices and components from a trusted medical plastics supplier.

Minimum Order Quantity: 1,000

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Plastic Injection Moulded Medical Components


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ISO Compliant Cleanroom

Our cleanrooms are contained spaces with technical provisions made to reduce particulate contamination in the air and control other environmental parameters (like temperature, humidity, and pressure).

To achieve this, all of the air delivered to our cleanroom passes through HEPA (High-Efficiency Particulate Air) filters.

These cleanroom regulations eliminate airborne contamination from people, equipment, materials, and industrial processes. This level of sterility is critical for medical products such as medical devices. 

Products produced in our cleanrooms can only be approved as safe for use if the machine area and conditions during manufacturing are safe from contaminants.

Class 7 Cleanroom with Climate Control

Each ISO compliant cleanroom receives its cleanliness classification based on the industrial application that the cleanroom operates in, the level of risk involved, and other environmental considerations.

Specifications

Our medical plastic injection moulding cleanroom has an ISO 14644-1 class 7 cleanroom validation.

This means it is a hard-sided wall manufactured facility utilising HEPA filtration systems to maintain air cleanliness levels of a maximum of 10,000 particles (≥0.5µm) per cubic foot.

Our class 7 cleanroom filtration systems have a minimum of 60 air changes per hour and a filter coverage of 15-25%. Class 8 cleanrooms, on the other hand, typically only have between 10-25 air changes every hour. The standard air-flow rate for our ISO class 7 filtration system is 9-16 CFM per square foot.

The production of most medical devices requires a class 8 cleanroom, but we have found better control in the HEPA filter system and environment systems of a class 7 cleanroom.

This meets the specifications of a standard that is one level higher than class 8.

Laminar Flow Cabinets

In our cleanroom, injection moulding production is done in a safe and clean environment with HEPA filters, and our four laminar flow cabinets aid this process dramatically. 

In our laminar flow unit, clean air has a single direction downflow from the face of the fan filter unit with no interruptions from turbulence.

This unidirectional downflow of clean air ensures that only extremely high-quality clean air passes down over the production, manufacturing, and assembly process, protecting sensitive medical devices and products from the risk of airborne particulate. This means that the environment will be free from any particles shed from operatives and any particles generated from the process.

Trained & Experienced Personel

At Plastech, we believe the control and maintenance of quality is the responsibility of all staff.

Our cleanroom has been designed for BS EN ISO 14644-1 class 7 validation and our experts have been trained according to the relevant facility conditions and processes.

Our staff are trained both in the cleanroom procedures and in the concept and system behind cleanroom manufacture to ensure we maintain hygiene standards and a clean environment when operating our injection moulding machines and while working with the various medical components.

Our Quality Management Systems are compliant with ISO 9001:2015.

Industries & Markets Supplied

Our plastic medical injection moulding components supply the medical industry with design and production solutions, no matter how complex the tool may be. 

Our pharmaceutical and medical device plastic injection moulding capabilities also support a number of related markets, industries, and sectors. These include:

  • Metered Infusion Burettes
  • Medical Devices
  • Ear, Nose & Throat
  • Dental
  • Veterinarian
  • Harm Reduction

Specialised Medical Components

Plastech's controlled environment manufacturing facility and cleanroom have been designed specifically for the manufacture of burette tubes, manometers, medical grade packaging, and small injection moulded components, but we are also able to design any other type of custom component and create the tools needed to produce it.

Cleanrooms can be expensive for medical and healthcare companies to maintain on their own.

With our certified engineering design team (ISO 9001:2015), we can provide a diverse and innovative range of high-performance medical injection moulded products at a cost-effective price regardless of quantity.

Injection Moulding Expertise

With our class 7 cleanroom, injection moulding production is something we specialise in. We even offer a wide range of component development services and added value services to ensure each plastic product produced at the Plastech facility is exactly what you need, right down to the labels.

Services

Injection moulding is a precise, cost-effective way of making medical components, but we go further than just production.

Our medical manufacturing services for component development include:

  • Product design using 3D CAD software
  • Rapid prototyping models
  • Tool design
  • Pre-production sampling
  • Manufacture

We know that many medical device businesses don’t have their own cleanroom, designers, tooling specialists, materials, or project managers. We provide our expertise as a solution to clients with a comprehensive range of design services, state of the art tooling, and project management.

We can manufacture a small and simple product to your exact specifications or work with you for the development of a full project for either a single product, a complex project, or a range of products.

The cleanroom, injection moulding machines, and manufacturing materials are ours; but the choices are yours.

Manufacturing Expertise

As a turnkey medical plastics solution, we also offer a full range of graphic design and printing services, including:

  • Design
  • Insert Moulding
  • Silk Screen Printing
  • Pad Printing
  • Hot Foil Blocking
  • Packing and Assembly
  • Contract Packing

Our wide range of capabilities means that we are also able to assemble and wrap your medical devices or products upon completion.

Our sterile medical device packing abilities are the product of years of developing our knowledge of sterilisation methods, medical and pharmaceutical plastic packing, regulatory processes, sealing and protection, and package integrity.

Facilities

Manufacturing is done within our class 7 cleanroom utilising a laminar flow unit to further avoid contamination during assembly. Our modern injection moulding machines have a production range of 30 to 150 tonnes.

Our medical injection moulding cleanrooms include:

  • 1 Coextrusion Line
  • 2 Injection Moulding Machines
  • 4 Laminar flow cabinets

Our production rooms have the capacity for both small and large orders of medical devices.

The HEPA filter bank (up to 9 filters) in our cleanroom removes 99.999% of particulate matter from incoming air. With constant monitoring and analysis of the conditions of the cleanroom, we are able to manage air contamination and ensure the best development of our technology going forward.

Our product design using 3D CAD software enables us to rapidly produce prototypes, speedily design tools, and facilitate pre-production sampling and manufacture both quickly and cost-effectively — all while ensuring a controlled level of contamination in our production rooms.

Our work surfaces are constructed from high grade stainless steel to ease cleaning and maintain the highest standard of hygiene.

A Wide Variety of Plastics

Our injection moulded medical components and devices can be made in one of many standard plastics.

These plastics include:

  • Low Density Polyethylene (LDPE)
  • High Density Polyethylene (HDPE)
  • Polyethene Terephthalate Glycol (PETG)
  • Cellulose Acetate (CA)
  • Flexi & Rigid Polyvinyl Chloride (PVC)

HDPE, LDPE, and PETG are all low-cost plastics that are resistant to moisture and chemicals.

CA is one of the most environmentally friendly plastics. It is a renewable plastic made from natural resources and is also recyclable. Acetate is durable, flexible, lightweight, and has hypoallergenic properties.

PVC is lightweight, recyclable, and relatively inexpensive. It combines environmental resistance with excellent tensile strength. It also offers good colour retention and excellent dimensional stability.

If you are unsure of which plastic is best for your injection moulded devices, our team will gladly advise you.

Give us a call on 01592 752212 to discuss your needs!

Medical Plastics Manufacturing Experts

Plastech has accumulated comprehensive knowledge and expertise in the manufacturing of low to medium volume precision moulded components. We are considered to be one of Scotland’s leading contract manufacturers.

Unparalleled Quality & Customer Service

We take pride in ensuring that every cleanroom, laminar flow unit, machine, and tool we use, and every label that we design, is of the quality for which we are known.

Every order is subjected to a stringent contract review process to ensure we have as much information as possible about the client's requirements before beginning production planning.

Then, regardless of size, we test each product extensively and follow strict guidelines to ensure all of our injection moulded products have undergone a number of checks to guarantee they are of the highest quality.

Get a Quote on your Medical Components

Plastech is vendor approved by a wide range of clients from the medical device industry. Plastech is a name synonymous with quality when it comes to the production of medical devices in our medical injection moulding cleanroom.

Our team is ready to advise you on any of our standard products or on custom-designed medical products that you may need. We strive to deliver same-day quotes when you send us your details and specifications via our simple online form.

Contact us for a quick quote on the medical device solutions you need!

"Plastech are vendor approved by a wide range of clients from the Medical Device Industry..."


Medical Injection Moulded Component