Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, medical devices, pharmaceutical products, and cosmetics. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The main purpose of GMP guidelines is always to prevent harm from occurring to the end user.
GMP covers the entire operation – everything from the materials used to employee personal hygiene. All guidelines follow a few basic principles, one of which is particularly relevant to Shoe Inn products:
Manufacturing facilities must maintain a clean and hygienic manufacturing area.
Procedures, like wearing personal protective equipment (PPE), help maintain the clean and hygienic manufacturing area and reduce the risk of contamination. Garments such as smocks, hair nets, beard covers, disposable gloves, and shoe covers are donned beforeentering critical environments and manufacturing areas. Oftentimes sticky mats, also known as tacky mats or cleanroom mats, are used in parts of facilities to pull contaminants off the bottom of street shoes prior to entering the gowning area or other sensitive areas. A newer technology that is being employed is the use of a UVC light sanitizing system to kill germs and pathogens on the soles of footwear.
When it comes to adhering to GMP protocols, Shoe Inn has a range of products that will definitely help with maintaining clean and hygienic manufacturing areas.
While many companies use shoe covers to prevent contamination, many Shoe Inn customers also use sticky mats to maximize contamination prevention. The utilization of multi-layer adhesive mats for cleanrooms is almost universal. However, how the mats are used is unique to each cleanroom. Mats can vary in size, color, number, and placement based on the logistics and characteristics of each individual cleanroom.
Mats should be placed in an area where they will be on clean, hard flooring. They should be placed just before or just after the ingress/egress point for each cleanliness or control change. It is suggested that the placement sites are worked backward from the final clean area or cleanroom.
cleanroom – gowning area
cleanroom – staging area
gowning area – control area
control area – common hallway
common hallway – warehouse or receiving
common hallway – public area
Matting should be placed so that all those passing through that point must step on the mats. Matting should be placed with the longer dimension of the mat in the same direction as the traffic flow for maximum footfalls on each mat. The minimum number of footfalls should be two with each foot for each location.
The proper size mat for each area of placement depends on the width of the opening and the variance and direction of the traffic. Normally the width of the mat should be 2/3rds to 3/4ths of the width of the doorway. It does not normally need to cover the full width because ordinary traffic passes through the middle of the doorway and not along the edge. However, if the traffic enters at a sharp angle or from the side of the entryway, then the width of the mat needs to be wider than the doorway to allow for enough footfalls.
As stated above, the length of the mat should be long enough to provide at least two footfalls with each foot at each location. Usually this is a minimum of 45 inches.
The color of the mats, which has no effect on the function of the mat, can vary from standard blue, white, and grey to custom colors and printed messages. In general, white shows the most dirt and particulates, and is normally preferred to make sure the layers are changed at frequent enough intervals. However, grey and blue work just as well when a maintenance schedule is set.
How often the layers should be removed depends on a number of factors:
How dirty the area the personnel are coming from is.
The number of people or pairs of feet per shift or per hour.
The difference in cleanliness between the areas.
The size of the mats and how many mats or locations are in the series.
In general, areas farther away from the cleanroom will be dirtier. Changing the layers at this point of use every half hour would be a benchmark with which to start. The final entry area into the cleanroom is probably from a clean area to a very clean area and each layer may last 4 to 8 hours.
However, this is just a rough guideline and each point of use will vary greatly. A few days of use and observation will help to determine the optimal mat layer change interval.
Before placing a new mat down or replacing an existing mat, thoroughly clean the surface to remove contamination that may act as a barrier and keep the mat from properly adhering to the floor. Make sure to remove any adhesive residue if you are replacing an existing mat. It is recommended to use a pre-saturated wiper that contains a percentage of isopropyl alcohol. Make sure the surface is completely dry before application.
To apply the mat, remove half of the release liner in the long direction of the mat, which will help with the alignment of the mat.
Once you have the mat properly aligned in the location you want, start smoothing out the half of the mat with the adhesive exposed. Start at one end and work toward the middle making sure you do not trap air under the mat as you go, then remove the rest of the release liner and smooth the rest of the mat out in the same direction in which you removed the release liner.
Matting should be stored flat and for several hours in similar climate conditions as the point of use. For ideal results, the mats should be used in a controlled environment setting but may be placed in any area that has a temperature of 54-95 oF (12-35 oC).
Long-term storage of mats should always be on a flat and hard surface. Storage on the original shipping pallet is recommended. Normal warehouse conditions are usually acceptable but extreme temperatures (less than 32 or greater than 105 oF / 0 or 40 oC) should be avoided.
Storage of mats longer than one year from the date of purchase is not recommended. However, under normal storage conditions, matting should not have any variation in performance for a period of up to three years.
The utilization of multi-layer sticky mats for cleanrooms is almost universal. In fact, many customers who use the Shoe Inn automatic shoe cover dispensing system also use these adhesive mats to further help prevent contamination within controlled environments. Depending on various factors such as how dirty the area the personnel are coming from is and the level of cleanliness desired or mandated, this combined approach may be advisable or even required.