Gloves are a type of personal protective equipment (PPE) that are used in many different environments, from hospital exam rooms to operating suites to semiconductor and pharmaceutical cleanrooms.
While cleanroom gloves may not look that different, the manufacturing process involves many different steps that are important for cleanroom customer applications. The primary purpose of wearing cleanroom gloves during manufacturing is to minimize submicron particles from the operator’s hands from contaminating the product or process being manufactured. Semi-conductor or any other electronic device manufacturing cleanrooms are designed to tightly control the level of particles. Pharmaceutical, biotechnology and medical device cleanrooms are designed to control microorganisms from contaminating these types of medical products and to ensure patient safety.
PPE must be produced with the right design, material and formulation, while maintaining the cleanliness of the product throughout the entire manufacturing process including in-house testing to ensure the level of particle and endotoxin cleanliness.
What factors are most important when manufacturing PPE that is destined for cleanrooms? And what manufacturing techniques contribute to the safe production of cleanroom PPE?
The process starts with having the right material and optimum formulation, which will create a product that can meet customer demands such as pliability level and class of cleanroom. Then, it is critical to maintain the cleanliness of the product throughout the entire manufacturing process. While exam gloves are manufactured on automated lines, inspected and shipped, cleanroom gloves require additional processing and rigorous post-processing steps after they come off the production line. All gloves are washed with chlorine and de-ionized water on both sides of the glove to remove surface particles, powder residues and extractables to very low levels. Cleanroom gloves then undergo extensive testing for physical properties such as the presence of particles and extractable ion content as well as barrier integrity and tensile strength. Gloves are then vacuumed-packed in multiple layers of cleanroom-compatible polyethylene packaging inside a Class-100 or ISO Class 5-controlled cleanroom.
This cleanroom environment is designed to maintain certain levels of particulates and airflow standards to protect the product during the post- processing and packaging steps. Another important element for cleanroom manufacturing customers is traceability of their cleanroom gloves. Tracking of gloves by lot and batch number from the glove manufacturer is critical to ensuring compliance with Good Manufacturing Practices per ISO Standards. The cleanroom glove packaging must have product lot and batch numbers as well as expiration dates on the packaging to ensure the product and its components or raw materials used to produce the gloves can be traced to their original supplier.
What should customers ask a manufacturer about their process before deciding to use their product?
When searching for a manufacturing partner, customers should ask about the type of quality controls that are in place to ensure consistent, safe production, what is the recommended ISO level of the gloves as well as recommended applications, and what’s the ability to provide technical documentation and support. Customers should be clear about the intended use of the gloves (class of the cleanroom and product they will be handling) and ask about special offerings, such as accelerator-free, that can be a benefit to cleanroom employees using the gloves. Lastly, they should ask if the manufacturer can tailor their process to meet their specific needs. For example, can they control the grip properties of the gloves?