Alex Butler, MasterControl, looks at the importance of cleanroom quality and planning and maintaining operations in the manufacture of medical devices.
During the manufacturing process of medical devices it is important that contaminants are absent from the process –which is why cleanrooms are used. In addition to reducing the safety and effectiveness of the medical devices, contamination in a cleanroom could lead to a shutdown, resulting in the loss of significant amounts of money and time.
Cleanrooms are especially important in the manufacturing process of plastic products that are becoming more prominent in medical devices. Impurities can cause defects in the products, which in turn can cause problems in the medical devices. Therefore, it is imperative that organisations have policies and procedures in place to maintain the environmental integrity of a cleanroom.
In order to have a pristine cleanroom, organisations must first understand the threats that could cause contamination of a cleanroom. Micro-organisms, dust/smoke, unapproved equipment, inadequate environmental controls and human error are among the leading causes of contamination in cleanrooms. In general, some research has shown that cleanroom personnel contribute to approximately 80% of all contamination that is found within the cleanroom.
In regards to plastics manufacturing for medical devices, injection moulds are a source of contaminants, especially if the moulds are not properly maintained. Other cleanroom contamination sources specific to plastics are dust that is released during production and contaminated raw materials.
There are some steps that companies can take to significantly reduce the risk of contamination, with a number of these preventative measures taking place outside of cleanrooms. Two good sources to look at before developing cleanroom policies and procedures are the Institute of Environmental Science and Technology recommended practices for contamination control and the ISO 14644 series of international standards for cleanrooms and associated controlled environments.
A quick overview of some of the best basic cleanroom practices includes:
- Developing a thorough cleanroom gowning requirements and procedures, such as what is to be donned and in what sequence.
- Ensuring the correct cleanroom supplies are present and they are used properly. This is important for not producing quality products but to protecting cleanroom personnel.
- Instituting cleanroom housekeeping procedures and schedules. This is common sense for not only cleanrooms, but for many different aspects many industries. Preventative maintenance is a good idea, especially for plastic mould injection equipment to reduce contaminants that are produced during the process.
- Training personnel on behavioural standards within the cleanroom environment. Carelessness and ignorance can lead to disaster.
- Continuously auditing and assessing cleanroom procedures and making improvements as needed. As technology advances with new types of materials and new types of devices, cleanroom procedures need to keep pace with the contamination threats and sources that may arise.
For organisations that need to build a cleanroom, they can get a headstart on contamination prevention with a sound facility design and floor-plan. One good tip from the Johns Hopkins Applied Physics Laboratory is to have a centralised air system that has air filters and fans to keep a predictable, clean airflow. A centralised air system also is important in regulating the conditions needed from drying the plastics.
According to Controlled Environments, facility design evaluation is the first phase of the five-phase cleanroom validation process, which is performed to ‘ensure that the design of the facility is fit for its intended purpose; to ensure that the facility, equipment, and environment meets User Requirement Specifications (URS)’. The other four phases are installation qualification, operation qualification, performance qualification, and the post-qualification monitor and control phase. The best cleanroom practices outlined earlier in this article play a key role in the cleanroom validation process.
Of course, in addition to having a good cleanroom program, medical device manufacturers must provide documentation of their efforts, such as information of sterility in 510(k) submissions. In the spring of 2016, the Food and Drug Administration issued the Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile which has updated recommendations regarding sterilisation processes that should be in 510(k)s for devices labelled as sterile.
As with all government regulations, it is strongly advised that medical device manufactures have a full understanding to of the new regulations, especially as it pertains to novel sterilising methods. An organisation using a novel sterilisation method will likely have to undergo a facility inspection by the FDA.
Maintaining efficient cleanroom operations requires careful planning that begins before the cleanroom is built and implementing proactive policies and procedures.