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How To Choose The Right Medical Contract Manufacturer?

Published On: April 4, 2024

Choosing the right plastic injection molding partner is crucial for the success of your product, particularly in industries with stringent quality and cleanliness standards. When selecting a partner, it’s important to ask the right questions to ensure they meet your production requirements and uphold the highest quality standards. In this post, we’ll offer some guidance to help you make an informed decision.

In the first section, we delve into key questions you should consider when assessing a potential partner’s capabilities. The second part of our post focuses on assuring quality within your chosen partner’s production system. We’ll discuss the role of a quality department and to keep compliant with all necessary standards and regulations.

Together, these sections provide a comprehensive overview of what to look for in a plastic injection molding partner to ensure your product is manufactured in a clean, efficient, and compliant environment.

To choose the right partner you need to ask some questions.

  1. Does my product require a clean room, or at least a portable clean room?
  2. Does the partner I am looking for make molds and run production?
  3. Do they follow standardized validation procedures like IQ, OQ, and PQ?
Does my product need a clean room?

Note that it can be said or written either way “clean room” or “cleanroom” according to Wikipedia. However ISO, the International Organization for Standardization uses the term “cleanroom” so in this article we will stay consistent with ISO.

A cleanroom is a facility designed to minimize and maintain a standardized level of airborne particulates. Cleanrooms are labeled most commonly by the ISO standard that is defined by the maximum particles per cubic meter of air in that particular room. The rating standards go from ISO 1 (10 particles per cubic meter >0.1 um) to ISO 9 (35,200,00 particles per cubic meter > 0.5 um).

At TechNH we have both a modular cleanroom and a portable cleanroom both class ISO 7.

Does my prospective molding partner make the molds and run production?

Some medical molders run production only. This may be fine for your need, however if there are any wear issues with your mold or you need to improve or change your design in any way then that would need to be done at a mold maker shop. TechNH has both a mold shop (also known as “tooling capability”) as well as production capability.

TechNH can help with designing your parts to achieve your production needs by assuring the design is production friendly, not every design is production friendly.

Do they follow standardized validation procedures like IQ, OQ, and PQ?

Validation is a critical process that establishes documentary evidence that a process or procedure or any production activity maintains the desired standards. Normally any validation procedure will include the IQ, OQ and PQ. IQ – is the Installation Qualification of the mold. OQ – is the Operation Qualification of the equipment and process. The PQ – is the Process Qualification of a production run.

TechNH has a complete quality and regulatory department ready to help you and your company.

Assuring Quality within the Production System

To assure that the highest standards are met on a consistent basis, all medical injection molders have Quality departments. In addition to this, a select group of injection molding companies have a key employee in the position of Management Representative who oversees the quality requirements, from a macro perspective. An industry rarity is a company that has a Management Representative and Regulatory Affairs staff overseeing all Quality and Regulatory requirements and activities.

The Management Representative reviews all ISO requirements (typically ISO 13485), and Regulatory Affairs reviews all FDA and other pertinent regulatory agency requirements, to support each Customer’s production requirements. Any company that chooses to have a Management Representative and Regulatory Affairs as part of their staff demonstrates their corporate commitment to meet the Customer’s Quality and Regulatory requirements.

Any Customer that utilizes their products within a regulated industry can be assured that the Management Representative and Regulatory Affairs will help them work through the requirements prior to production.

If you want the highest quality production environment, be sure that you choose a contract manufacturer that has a Management Representative and Regulatory Affairs on staff.

Contact us today to discuss your project requirements and discover how our expertise and capabilities can bring your vision to life. With TechNH as your partner, you can expect exceptional quality, precision, and reliability every step of the way.

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