What is a GMP facility?
GMP stands for “Good Manufacturing Practices”. A GMP facility is one that commits to certain protocols that ensure the manufacturing of products according to quality standards. Their goal is to prevent any possibility of contamination, mix-ups, deviations, or errors in the final product. What distinguishes GMP from standard quality assurance is that it requires constant monitoring throughout the production, and not just the final product. It covers every aspect of production – starting with the raw materials, premises and equipment to the training and personal hygiene of staff.
What are the main protective requirements in a GMP facility?
Protocols differ from one GMP facility to another, but they all tend to follow the same general protective requirements. Standard Good Manufacturing Practices include the proper maintenance of production floors, facility and equipment monitoring, record keeping, and much more. In an attempt to make sure that the production process is as safe as possible to produce risk-free and reliable products, the starting point for such protocols would be hygiene: the cleanliness of the premises and the personal hygiene of staff are primary protocol. GMP calls for certain gowning procedures that vary from one facility to another, but generally include the wear of disposable gowns, face masks, gloves, bouffant caps, and shoe covers.
What shoe covers to use for the protocols?
GMP facilities have designated transition zones where employees and visitors must pass to enter the “Clean” zones. Consider the typical routine: they enter the changing room and follow the daily steps of the gowning procedure. The last step of this process before crossing over to a “Clean” zone is putting on shoe covers. The basic protocol for shoe covers in a GMP facility requires that shoe covers worn on a production floor must not leave the building, and that they have slip-resistant soles. Such protocols are especially important in facilities with cleanrooms, where preventing contamination is exceptionally important and several types of shoe covers are often used.
Using more than one type of shoe cover is common among GMP facilities, especially since moving from one zone to another often requires different shoe covers due to their different properties. Shoe covers also have twofold use: they can protect shoes from contaminated environments, and can protect environments from contaminated shoes. Some facilities use dedicated shoes on production floors, while others use shoe covers. Protecting these shoes when leaving their “Clean zone” to the cafeteria, reception, or bathroom is crucial – and is easy to achieve with polypropylene shoe covers. BlueMed’s Wave shoe covers are an example of shoe covers that are great for transition zones. Likewise, these shoe covers can be worn to protect clean floors or transition areas from contaminated shoes.
Once in the “Clean zone” of a facility, there is a variety of shoe covers to choose from depending on the facility’s specific needs. Choosing the right type of shoe covers comes down to three key things: the type of floor, the environment, and the type of product being manufactured. A facility that manufactures products using powders or glycerin that cause slippery floors, for example, would benefit from extra anti-skid shoe covers, such as our Cosmic shoe covers. Production areas with wet floors on the other hand would require sturdy waterproof foot protection, such as Azure shoe covers, which are also very handy for contractors as they provide the required durable and heavy-duty protection. Shoe covers come in different fabrics and designs, and each facility can find the right combination of shoe covers to use for GMP protocols.
Should GMP facilities use shoe cover dispensers?
Before entering a “Clean” zone, all employees and visitors need to pass cross-over benches. They enter changing rooms where they begin the gowning process – last of which is slipping on shoe covers. This whole process takes up to 10 minutes or more each time someone enters or reenters the facility, which realistically happens several times a day. It is especially time-consuming when large groups of people are gowning themselves all at once, which is often the case. Naturally, people lose the motivation to conform to the rules of gowning the more often they have to go through the entire procedure. Replacing these benches with shoe cover dispensers would facilitate the application of shoe covers in a quicker, cleaner, and safer way.
If you have business challenges or custom requirements that you would like to discuss with us, please feel free to call us at (514) 678-0930.
The BlueMed Marketing Team