Cleanroom Packaging Manufacturing


 

Dordan has an in house ISO Class 8 certified cleanroom for the production of custom thermoformed medical packaging. A fully enclosed and of complete hardwall construction, Dordan's cleanroom works to mitigate the level of particulate and biological agents present in the manufacturing environment.

Dordan's ISO Class 8 Cleanroom


Family-owned custom packaging designer and thermoformer since 1962.

Dordan's cleanroom houses Keifel thermoforming machines with sophisticated forming, cutting, stripping, and stacking stations. These plastic thermoformers have advanced machine controls and programming capabilities, allowing for the production of consistently high quality medical packaging. All cleanroom tooling and ancillary components are designed, produced, and assembled in house.

Dordan's ISO 9001: 2015 quality management system dictates all cleanroom operating procedures to ensure that the packaging being manufactured meets the quality, cleanliness, and performance criteria of its customers.

As a fully-integrated medical packaging supplier with in house thermoform design, tooling, and manufacturing, Dordan provides thoughtfully-engineered and high quality medical packaging in quick turnaround at competitive pricing.

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Cleanroom Thermoform Tooling and Equipment


Stainless steel heated dies & form tools, syntactic foam assist plugs, and custom designed and built strippers and stackers.

  • Heated cutting dies with strategic tag placement allow for clean cutting, reducing fiber hairs and tags on the flange of the formed part.

  • Stainless steel dies, build ups, and form tools, married with syntactic foam assist plugs, allow for production of consistent and high quality thermoformed medical packaging.

  • Custom designed and built in house strippers and stackers facilitate efficient thermoforming  of medical packaging.

  • Formed, stripped, and stacked parts are indexed forward via conveyor belt where they are moved to stainless steel inspection tables for quality control measurement, documentation, and analysis.

  • Verified to spec, parts are double bagged and placed in air tight pass-throughs for secondary packing.

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Cleanroom Manufacturing Quality Control


Prep | Inspect | Monitor | Document | Report | Analyze

Dordan's cleanroom production SOP is governed by comprehensive documentation and procedures.

  • All cleanroom production staff are trained in protocols and etiquette before entering the cleanroom, while operating within the cleanroom, and upon departure. Cleanroom staff are fitted with gowns, booties, hair nets, and gloves; each entry to the cleanroom requires a new set of gear.

  • Staff gown up in a separate room that is within the cleanroom hardwall construction, which has lower air pressure then the cleanroom, ensuring that upon entry, air is pushed out of the cleanroom into the gowning room.

  • Material rolls and tooling is de-skidded and wiped down with FDA certified cleaning agents, prior to being brought into the material staging room; this has lower air pressure then the and outside facility. After entry to the material staging room, the overhead door to is closed, creating an air tight chamber. Once the door to the outside facility is closed, the door to the cleanroom is allowed to open; the material is brought into the cleanroom utilizing custom designed material handing equipment certified for use in a cleanroom.

  • Strict terminal cleaning protocols with comprehensive sterilization procedures ensure the continued cleanliness of the cleanroom, gowning room, and material staging room.

  • Particulate counts are performed per a set schedule to monitor air quality; and, performance is tracked to verify and validate conformance to the environmental standards set forth in ISO.

  • Environmental monitoring risk assessments are performed quarterly to help identify risks and opportunities for continuous process improvements.

  • Dordan utilizes automated optical inspection equipment to rapidly determine the thermoforming process capabilities to establish the benchmark off which future production is monitored. The CPK data and analysis is provided to customers for incoming material inspection and verification.

  • Dordan provides various tiers of quality control procedures, depending on its customers' requirements. These include, but are not limited to, first article inspection validation, process validation, PPAPs.

  • Once the first article inspection is performed, Dordan's Engineering Department generates a final production drawing that includes the package design, specifications, and real-time production tolerances. 

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