Ashley Philipp, marketing director, Injectech, explains the benefits cleanrooms can offer manufacturers.
“In the medical industry, you have to do it, it’s a no brainer.” This was the response received when a production manager with 20 years of experience moulding plastic components for medical devices was asked about cleanroom manufacturing.
A cleanroom environment provides stability, reliability and control over the moulded fittings, these attributes are translated to the medical devices which are then used in patient care and surgical procedures.
One of the top factors impacting the decision whether to outsource manufacturing, and if so, which company to outsource to, is whether or not components are cleanroom manufactured. Both fitting and medical device manufacturers will be able to recognise the positive impact they can have on their processes, procedures, and outcomes by understanding the benefits of cleanrooms.
Cleanrooms are regulated and classified by the International Organisation for Standardisation (ISO) in the United States and Canada by ISO 14644-1. This regulation includes cleanroom classes from one to nine with one having the highest degree of cleanliness and nine being the least clean. The most common classes of cleanroom environments are ISO class 7 and ISO class 8. A cleanroom class is determined by the cleanliness of the space in compliance with the quantity and size of the particles per volume of air allowed. Air purity is achieved through High Efficiency Particulate Air (HEPA) filters. A cleanroom serves to ensure small particles don’t affect the manufacturing process through control of humidity, temperature and pressure within the environment.
Medical devices and the parts used in tandem with them fall under intense scrutiny for cleanliness and sterility by governing bodies such as ISO and the Food and Drug Administration (FDA). Cleanroom manufacturing offers reassurance to medical device manufacturers that the fittings they have chosen to incorporate into their device will comply with their regulatory requirements.
By manufacturing, assembling, inspecting, and bagging the plastic components inside a cleanroom the ability to meet sterility and regulatory compliance is easily achievable. Cleanroom environments must comply with their own set of standards, and therefore set the ground work for compliance with medical device standards.
Cleanroom environments provide increased reliability for the manufacturer as everyday contaminants, dust and other particles are eliminated so as to not affect the processes or the fittings. Component manufacturers want to instil the same trust in their fittings as medical device manufacturers want to instil in the hospitals using their devices. It is very important that the company offering cleanroom manufacturing is visited because companies may claim to have cleanroom manufacturing, however it could only be one machine within a cleanroom. This can then result in conflicts or issues such as delays if the production schedule for this machine is busy or if the machine breaks down. Another item which is important to review is the actual testing of the cleanroom. It is important to make sure the room has been tested in a ‘running’ state along with an ‘at-rest’ state. The ‘at-rest’ test provides a better cleanliness report as there are no people or moving machines, whereas the ‘running’ state will show exactly how clean the room is during manufacturing.
Manufacturing in a cleanroom demands a high level of training and competency of the personnel inside to maintain the environment standards and overall cleanliness. The individuals chosen to assemble, inspect, and bag fittings in the cleanroom have undergone extensive training that reflects the needs of the ISO requirements. The required competency and heightened attention to processes by individuals performing the procedures provides greater accountability from those inside and outside of the cleanroom.
A cleanroom provides an elevated amount of control over the operations and functionality that can assure medical device manufacturers that the parts they are receiving will be reliable. With the benefits of efficiency, competency, accountability and ability to comply with sterility and regulatory standards, cleanroom manufacturing truly is a ‘no-brainer.’