More than just a part of the manufacturing process, quality assurance is the benchmark for success at Plastek. It is built into every aspect of operations and every job function company wide.
A comprehensive quality assurance program is implemented throughout the entire manufacturing cycle. In order to reach success in the quality process of our customers products, every employee at Plastek follows controlled procedures, work instructions, visual standards and quality plans to produce plastic injection molded parts that will meet or exceed the expectations of the customer.
BRC AA/lOP Issue 5
ISO 9001 V 2018 – Quality
ISO 14001 – Environmental
ISO 45001 – Health & Safety
ISO 13485 – Medical Devices
FSSC 22000 – Food Safety
ISO 9001 v2008 -Quality
ISO 14001 v2004 – Health & Safety
Total Quality Management & Good Manufacturing Practices
The Plastek Group maintains a documented quality control management system designed and implemented to fulfill ISO 9001 requirements. This system creates a framework for clearly defining the control of materials, processes, and verification activities, thus providing our customers with confidence that the design and manufacture of The Plastek Group products are performed in a well-defined and controlled environment.
The Good Manufacturing Practice(GMP) requirements specified in The Plastek Group manual are designed to :
Establish guidelines consistent with The Plastek Group’s Quailty policy, which conform to applicable regulatory requirements for the manufacture and distribution of consumer product packages, medical devices, and other products
Aid employees to maintain the high quality standards of products manufactured and distributed by The Plastek Group.
Instruct employees about good sanitation practices
Stress the importance of personal hygiene and cleanliness
Plastek is committed to producing zero defects. The quality of any part depends on the quality of the material used. Every lot of resin delivered to Plastek is put through a comprehensive series of tests in our on site materials lab, before we accept it for production.
This includes ASTM standard test methods such as melt flow, tensile and density tests.
In addition, we perform other product specific tests developed by the Plastek Quality Materials Lab for the raw materials utilized, such as colors, labels, and liners.
Thanks to a long-standing supply into the nutrition, pharmaceutical and food grade market, Plastek acknowledges there are needs and values important to our customers.
Products are made under strict regulations, policies and procedures following GMP guidelines, to insure our customers receive a product, which meets or exceeds requirements.
We have available, a static and modular class 7 clean room as well as a white room facility , guaranteed to provide environmental controlled conditions and production flexibility.
Plastek also maintains a master drug file as needed and is compliant with six specific FDA regulations .
111 (Dietary Supplements)
820 (General Quality Systems)
Plastek employs a team of highly experienced employees that specialize in metrology to satisfy our Customers requirements.
We perform daily inspections on all parts that have been produced following industry standard tolerances.
MicroVu, Automated Vision Measurement Systems.
Coordinate Measurement Machines (CMM’s)
Melt Flow and Volume testing
Density/Specific Gravity testing