Plastic Medical Disposables and Medical Device Manufacturing

Plas-Tech Engineering (Plas-Tech) specialises in medical device manufacturing and plastic medical disposables. It is also well known for its expertise …

Pre-filled syringes and syringe tubs

Plas-Tech Engineering has a line of high-quality syringe sizes provided in low extractable or leachable glass replacement materials such as cyclic olefin polymer (COP) by Zeon and cyclic olefin copolymer (COC) by Topas and more recently, viveon cyclic block copolymer (CBC).

Other commodity materials are also available, including polypropylene (PP), acrylic (PMMA), polycarbonate (PC), copolyester (PETG).

Glass replacement and silicone-free syringes

Plas-Tech glass replacement syringes provide a silicone-free option to prevent silicone leaching, making them suitable for biologics (protein-based) and ophthalmic applications. Standard or customisable options are also available for any application.

These syringes are available with the International Organisation of Standardisation (ISO) standard Luer locks with finger grips or in a tub fill configuration.

Made of either COC, COP and CBC, Plas-Tech syringes can be supplied with graduations or even with company logos for any branding requirement. Packaging is available in bulk or via the company’s new SmarTUB® syringe tubs for automated filling lines.

Design and engineering support

Plas-Tech Engineering has an ‘early design involvement’ approach with an engineering focus to assist its customers with custom part / product design constraints to achieve an ideal balance between pricing relevant to tooling and manufacturing.

For clients interested in low volume or even high volume, Plas-Tech can suggest a best-case pricing scenario to fit individual start-up cost targets.

If looking for flexibility in volume assumptions, the company offers manufacturing options that allow for market growth based on any projection.

Plas-Tech’s expertise in tooling optimisation and design consistently gives its customers exceptionally high-quality and competitive with other domestic sources; the company’s key to success is flexibility.

Mould manufacturing

Plas-Tech’s manufacturing operations include an in-house and temperature-controlled mould manufacturing / fabrication operation. The company’s mould shop is complete with long-time, experienced mould makers and no outsourcing is required.

With in-house, modern CNC hard machining technology, close tolerances and temperature controls, specifications can be met by all Plas-Tech injection moulds, enabling the company to offer the highest quality moulds made to its stringent requirements.

Cleanroom injection moulding

Plas-Tech offers cleanroom injection moulding (down to ISO Class 7), cleanroom medical assembly (ISO Class 6), cleanroom pad printing, laser marking and spray deposition coatings for syringe manufacturing, operations set up to operate unattended for 24-hour manufacturing.

All machines are centrally monitored and tracked digitally using a specialised integrated quality management system enterprise resource planning (IQMS ERP) system.

Cleanroom assembly specialities

Plas-Tech assembly operations function in ISO Class 6 and Class 8 environments, where the company performs automated assembly, manual assembly, ultraviolet (UV) and solvent bonding, packaging (tray sealing and pouching), decorating, labelling, kitting, Tyvek sealing and more.

The company’s newest cleanroom is home for a permanent ultrasonic wash system, allowing it to perform any parts washing required for a project.

Certifications and registrations

Plas-Tech Engineering is an ISO 13485 Certified and the US Food and Drug Administration (FDA) registered corporation, registered as a Class II Medical Device manufacturer. Coupled with its ‘Live’ MRP / ERP solutions – ZERO DEFECTS OUT THE DOOR and on-time delivery are the cornerstones of the company’s mission.

The company provides its customers with a choice, depending on the device or component requirement for clean moulding and secondary operations.

White room moulding that consistently measures to ISO Class VIII (100,000) standards, mobile press side cleanroom moulding at the ISO level required by the customer and ISO Class VI (1,000) cleanroom for secondary operations, assembly and packaging.

Validations and sterility

For the company’s medical device and syringe customers that require high-level validations, Plas-Tech operation fully supports installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) process validations, sterilisation validation and shipping / packaging validations for sterile medical devices.

Regardless of the size of the project, a plan can be developed for each project by individual regulatory requirements.