Cleanroom molding applications can be done on a variety of medical devices. A good ISO 7 clean room is available for packaging services and contract assembly. Build custom fixtures and use automation to ensure efficient assembly processes for simple or complex operations. Packaging services provided in ISO 7 cleanrooms cover a wide range of medical, pharmaceutical and dental products.
An effective ISO 8 cleanroom can accommodate different injection molding machines, including vertical presses. Such equipment can be used to manufacture the following products:
1. Medical equipment shell;
2. Surgical instruments;
4. Emergency room products;
5. Fluid delivery device;
6. Fluid transport container;
7. Heart products;
8. Blood transport shell.
Other products that can be manufactured include pediatric equipment, medical imaging, dental products, and scientific and research equipment.
One of the procedures for qualifying as a cleanroom for the manufacture of medical devices is to obtain the required certifications. Such certifications include GMP, FDA and ISO 13845:2016.
Good Manufacturing Practice (GMP) is a system responsible for ensuring consistent manufacturing and control of products to quality standards. The system is designed to reduce any production-related risks and covers all aspects of the production process. Each process requires detailed written procedures to ensure that the quality of the finished product is up to standard. These measures will ensure quality control during clean room injection molding.
It is important that the cleanroom is in a controlled environment to ensure that the plastics used to make these medical devices are free from contamination by dust and other particles. According to the Medical Device and Diagnostics Industry magazine, the U.S. Food and Drug Administration (FDA) requirements state that in cases where product quality is affected by environmental conditions, "manufacturers shall establish and maintain procedures to adequately control these environmental conditions." To establish this control, clean room fabrication is required.
1. Program files
The regulation and maintenance of cleanroom certifications, protocols and accreditations for medical device injection molding is comprehensive. Cleanroom injection molding machines must strictly adhere to many variables to ensure they meet standards. These variables include quality control systems that check, control and eliminate dust and particles that do not meet ISO 7 and ISO 8 cleanroom standard specifications.
For this reason, program files must be in place. Procedure documentation shall be implemented to ensure that controlled conditions can always be verified in the event of customer requirements, routine inspections, procedure deviations, or repeated cycles. Such procedural documents should actually monitor the die pull cycle, process life cycle, and product/equipment testing.
2. Risk management of clean room injection molding
Risk management is carried out by implementing specific analysis modules such as Fault Tree Analysis (FTA), Hazard Analysis and Critical Control Points (HACCP), Failure Mode and Effects Analysis (FEMA). When microbial risks are known and assessed, molders will be able to develop ongoing assessments to control contamination during manufacturing. In this way, injection molders will also be able to determine the level of acceptability in the manufacturing process through plastic injection molding process monitoring.
Some FDA-regulated implantable medical products can cause adverse and serious health effects when left unmonitored. Therefore, batch traceability is required for risk management.
Through the batch number, the processes involved in the manufacturing process can be traced to ensure that risks are managed. Lot traceability monitors the ingredients, component parts, equipment and labor involved in the manufacture of a product. Consumers can also contact manufacturers and research the production of goods by using the identifiers given by batch traceability.