In many markets, such as baby bottles, food and drink, cosmetics, supplements and electronics, it is imperative to keep the manufacturing process of plastic products clean and sterile. However, the pharmaceutical and medical industries are held to even higher standards regarding cleanliness and sterility. A clean room environment for pharmaceutical, medical applications and labware manufacturing is especially important to prevent exposure to dust, bacteria and other contaminants. In addition to compromising the safety and effectiveness of the products, contamination could lead to a company’s shutdown, resulting in the loss of time, money and reputation.
At Flexcraft, we know how imperative it is to conform to cGMP standards which is why we follow strict clean room policies and procedures at every step of the molding process.
What is a Clean Room Environment?
A clean room is a controlled environment used in any industry where it is necessary to control small particles that could adversely affect the manufacturing process. They are extensively used in the pharmaceutical, biotech and medical industries as well as industries with critical manufacturing processes such as aerospace, military and cosmetics.
A clean room is also defined as a facility utilized for scientific research or industrial production. In regards to plastics manufacturing for pharmaceuticals, the machines and environment must be sterile and protect products from contamination by keeping pollutants such as airborne microbes, chemical vapors, dust and contaminants, within strict limits.
Conforming to CGMP Standards
Clean rooms used within the pharmaceutical industry are regulated to meet the appropriate cleanliness quality levels required and defined by governing authorities, such as the U.S. Food and Drug Administration. Current Good Manufacturing Practice (CGMP) regulations enforced by the FDA are defined as:
“Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.”
High cGMP standards are typically ensured through the effective use of a quality management system aligned with ISO9001:2015 built into the manufacturing process at every step. Manufacturing environments that are kept in good condition with properly maintained and equipment, qualified employees and reliable processes are just a few ways that cGMP requirements can help to assure safety and efficacy.
Following Strict Policies and Procedures
The pharmaceutical industry is heavily regulated which means clean room environments are held to stringent requirements; they must follow strict policies and procedures. Some key components to maintaining a clean room environment for pharmaceutical manufacturing include (but are not limited to):
- Customizing quality plans for each project’s needs and requirements
- Controlling environmental parameters, such as temperature, pressure and humidity
- Ensuring HVAC system specifications meet requirements
- Filtering air into High Efficiency Particulate Air (HEPA) filters with a 99.99% efficiency to trap particles that are 0.3 micron and larger in size
- Inspecting raw materials
- Selecting and supervising personnel who have been extensively trained in contamination control regarding cGMP manufacturing
- Auditing internal procedures to verify all systems are seamlessly coordinated
Flexcraft – The Pharmaceutical Plastics Molding Company You Can Trust
As an ISO 9001:2015 Certified blow molder, our number-one priority is to provide only the highest quality of manufacturing, delivered on time and above expectations. At Flexcraft, we review the path of travel for every process providing the confidence our clients need to ensure processes are clean, contained and meet required specifications.
Whether you require sterile labware or medical devices, Flexcraft has the vast experience, quality in-house resources and a strong reputation for delivering quality to clients nationwide. To learn more about working with Flexcraft or request a quote, please call 732-502-9500 and speak with one of our representatives today.
