GMP and Shoe Inn Products

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 is always to prevent harm from occurring to the end user.[1]

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.

glovesProcedures, 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 beforeAll-shoe-covers-on-shoes-500entering 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.

Shoes on sticky mats

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.

[1] https://en.wikipedia.org/wiki/Good_manufacturing_practice

Shoe Covers in Specific Industries: Food

Cleanliness is vital in the food manufacturing/processing industry (growers, processing plants, etc.) in order to prevent contamination and avoid negative food safeiStock_000013166962Smallty headlines. Along with thorough hygiene practices and sanitation, wearing personal protective equipment such as gloves, beard covers, hairnets, and shoe covers can make a significant difference in reducing food contamination. Here are a few reasons why Shoe Inn shoe covers are crucial in the overall food industry:

  • Decreasing Outside Contamination

Tracking outside contaminants into clean environments on the bottoms of shoes is a iStock_000019685054XSmallpotential health hazard in the food industry. New shoe covers are clean and will keep any outside contaminants contained inside the covers, thereby preventing them from being introduced into food products.

Just as it is important to not introduce outside contaminants into the sanitary environment where food is processed/handled, it’s equally important to ensure nothing from the shoe covers gets left behind. Fortunately, the clips on Shoe Inn shoe covers have been designed so that they remain in place during application, wear, and removal.

  • Increasing Safety

Spills happen in the food industry and can be a significant safety hazard in terms of slipsunlucky carefree business man silhouette and falls. Some shoe covers are liquid proof and include non-skid/anti-slip coatings, helping to decrease slipping incidents and thereby promote safety.

Bottom line, shoe covers are an important piece of an overall food safety program and can also improve workplace safety in the food industry.

USP 800 versus 797: New Guide for Handling Hazardous Drugs Includes Shoe Covers

USP <800>, the U.S. Pharmacopeial Convention’s new standard for handling hazardous drugs (HDs) in healthcare settings, includes significant safety standards for all healthcare workers, as well as patients and the general public, who have access to facilities where HDs are prepared. This includes pharmacists, pharmacy technicians, physicians, nurses, physician assistants, home health care workers, veterinarians, and veterinary technicians.  Entities that store, transport, prepare, or administer HDs are also affected, including but not limited to pharmacies, hospitals, patient treatment clinics, physicians’ practice facilities, and veterinary clinics.

USP <800> provides facilities with direction on how to set policy and identify what needs to be done for employee safety while compounding and dispensing HDs. These new safety standards expand upon USP <797>, which focused primarily on minimizing the risk of contaminating medicines when compounding sterile IV preparations. USP <800>, on the other hand, is aimed primarily at addressing the entire life cycle of an HD so that all who might come in contact with it are protected.

USP <797> and <800> are related in that each refer to a chapter in the US Pharmacopoeia.  USP <800> is not just limited to chemotherapy but also many drugs that now fall under the National Institute for Occupational Safety and Health (NIOSH) list.  USP <800> has a minor component that currently falls under USP <797> this year but will become fully enforceable in December 2019 and will require full cleanroom and garbing precautions.  USP <797> is under revision; therefore the current version will hold until at least the next year.  This is the year the Joint Commission and Center for Medicare and Medicaid Services (CMS) is requiring compliance with USP <797>.  Since this is the first year that the CMS plans to enforce the IV compounding regulations, most facilities are scrambling to meet compliance.

Health Effects Resulting from Exposure to Hazardous Drugs

Green barrels with toxic substancesGrowing evidence, which has been accumulated over decades by the USP, Hematology/Oncology Pharmacy Association, Oncology Nursing Society, American Society of Clinical Oncology, and the Centers for Disease Control and Prevention indicates that occupational exposure to the more than 200 HDs commonly used in healthcare settings can cause acute and chronic health issues. In addition, over 100 studies have documented evidence of HD contamination in the workplace, including the presence of HDs in workers’ urine. With nearly 8,000,000 healthcare workers exposed to HDs each year, USP <800> aims to prevent associated acute and long-term health effects.

Required Upgrades Under USP <800> Include Shoe Covers

Personal protective equipment (PPE)(gowns; head, hair, and shoe covers; and two pairs of chemotherapy gloves) is required for compounding both sterile and non-sterile HDs, and two pairs of such gloves are required for administering antineoplastic HDs. Facilities also need to develop standard operating procedures regarding appropriate PPE for any workers who otherwise handle HDs.

Both USP <797> and <800> include several references to shoe covers as detailed below.

Compliant Shoe Covers + Automatic Shoe Cover Application and Removal

Shoe Inn’s shoe covers meet USP <797> and <800> guidelines.  If you want to take make Happy-doctors-smallputting shoe covers on faster, easier, safer and cleaner, go with an automatic shoe cover dispenser like the Shoe Inn Stay. You can even take it a step further by implementing an automatic shoe cover remover.  These products help eliminate workplace injuries, prevent contamination, and save precious time (see just how quick and easy in our application and removal videos).

USP <800> became effective on July 1, 2018.

***

USP <797> references to shoe covers

Appropriate personnel protective equipment (PPE) shall be worn when compounding in a BSC or CACI and when using CSTD devices. PPE should include gowns, face masks, eye protection, hair covers, shoe covers or dedicated shoes, double gloving with sterile chemo-type gloves, and compliance with manufacturers’ recommendations when using a CACI.

After donning dedicated shoes or shoe covers, head and facial hair covers, and face masks…

When compounding personnel exit the compounding area during a work shift, the exterior gown may be removed and retained in the compounding area if not visibly soiled, to be re-donned during that same work shift only. However, shoe covers, hair and facial hair covers, face masks/eye shields, and gloves shall be replaced with new ones before re-entering the compounding area, and proper hand hygiene shall be performed.

Appendix I: Order of compounding garb and cleansing in ante-area: shoes or shoe covers, head and facial hair covers, face mask, fingernail cleansing, hand and forearm washing and drying; non-shedding gown.

Appendix III: Dons shoe covers or designated clean-area shoes one at a time, placing the covered or designated shoe on clean side of the line of demarcation, as appropriate.

Appendix III: Removes shoe covers or shoes one at a time, ensuring that uncovered foot is placed on the dirty side of the line of demarcation and performs hand hygiene again. (Removes and discards shoe covers every time the compounding area is exited).

USP <800> references to shoe covers

Gowns, head, hair, shoe covers, and two pairs of chemotherapy gloves are required for compounding sterile and non-sterile HDs.

Head and hair covers (including beard and moustache, if applicable), shoe covers, and sleeve covers provide protection from contact with HD residue. When compounding HDs, a second pair of shoe covers must be donned before entering the C-SEC and doffed when exiting the C-SEC. Shoe covers worn in HD handling areas must not be worn to other areas to avoid spreading HD contamination and exposing other healthcare workers.

Cleanrooms

Cleanroom scientists wearing shoe coversCleanrooms (or clean rooms) are used in virtually every industry where small particles can adversely affect the manufacturing process.  Typically located in scientific research or manufacturing settings, a cleanroom is a controlled environment that has a controlled level of contamination (pollutants such as dust, airborne microbes, chemical vapors, and aerosol particles) that is specified by the number of particles per cubic meter (m3) or per cubic foot (ft3) at a specified particle size.  Believe it or not, the ambient air outside in a typical city environment contains about 35,000,000 particles per m3, 0.5 μm and larger in diameter, which corresponds to an ISO 9 cleanroom.  At the other end of the spectrum, an ISO 1 cleanroom allows no particles in that size range and only 12 particles per m3 of 0.3 μm and smaller.

Cleanroom Overview

A cleanroom is any given contained space where provisions are made to reduce particulate contamination and control other environmental parameters such as pressure, temperature, and humidity. The key component is the HEPA (High Efficiency Particulate Air) filter that is used to trap 99.97% of particles that are 0.3 microns and larger in size. All of the air delivered to a cleanroom passes through HEPA filters, and in cases where more stringent cleanliness performance is necessary, ULPA (Ultra Low Particulate Air) filters are employed.

The use of multi-layer adhesive mats for cleanrooms is almost universal.  Matting can vary in size, color, placement, and number based on the characteristics and logistics of each individual cleanroom.

Personnel who work in cleanrooms go through extensive training in contamination control theory, practices and procedures. They enter and exit the cleanroom through air showers, airlocks, and/or gowning rooms, and they must wear special clothing designed to trap contaminants that are naturally generated by our bodies.

Depending on the room classification or function, personnel gowning may be as limited as lab coats and hairnets/beard covers, or as extensive as being fully enveloped in multiple layered bunny suits with self-contained breathing apparatus.  The cleanroom clothing itself must not release fibers or particles to prevent contamination of the environment.

Cleanroom garments include things such as boots, shoes, shoe covers, beard covers, hairnets, bouffant caps, facemasks, coveralls, aprons, frocks/lab coats, gowns, glove and finger cots, hoods, and sleeves. The type of cleanroom garments used reflects the cleanroom classification and product specifications. For example, Class 10,000/ISO 7 cleanrooms may use simple smocks, head covers, and shoe covers.  On the other hand, careful gown wearing procedures with a zipped coverall, boots, gloves and complete respirator enclosure are required for Class 10/ISO 4 cleanrooms.

Cleanroom technicians wearing shoe covers
Cleanroom technicians wearing shoe covers

Air Flow Principles for Cleanrooms

Cleanrooms maintain particulate-free air through the use of either HEPA or ULPA filters employing laminar or turbulent air flow principles. Laminar, or unidirectional, airflow systems direct filtered air downward in a constant stream. Laminar airflow systems are typically employed across 80% to 100% of the ceiling to maintain constant air processing and unidirectional flow. Laminar flow criteria are mandated in ISO 1 through ISO 4 cleanrooms.  Turbulent, or non-unidirectional, air flow uses both laminar air flow hoods and non-specific velocity filters to keep cleanroom air in constant motion, although not all in the same direction. The rough air seeks to trap particles that may be in the air and drive them towards the floor, where they enter filters and leave the controlled environment.

Proper cleanroom design encompasses the entire air distribution system, including provisions for adequate downstream air returns. In horizontal flow applications, this involves the use of air returns at the downstream boundary of the process.  In vertical flow rooms, it requires the use of low wall air returns around the perimeter of the zone.  It should be noted that the use of ceiling mounted air returns is contradictory to proper cleanroom system design.

Cleanroom Classifications

Cleanrooms are classified by how clean the air is according to the number and size of particles permitted per volume of air. Federal Standard 209E is used here in the U.S.  The newer standard is TC 209 from the ISO (International Standards Organization).  Both standards classify a cleanroom by the number of particles found in the laboratory’s air. The cleanroom classification standards 209E and ISO 14644-1 require specific particle count measurements and calculations to classify the cleanliness level of a cleanroom or clean area.

Large numbers like Class 1,000 or Class 100,000 refer to FS 209E, and denote the number of particles of size 0.5 µm or larger permitted per ftof air. The standard also allows interpolation, so it is possible to describe other classes such as Class 2,000.

Small numbers refer to ISO 14644-1 standards, which specify the decimal logarithm of the number of particles 0.1 µm or larger permitted per mof air.  For example, an ISO 4 cleanroom has at most 104 = 10,000 particles per m³.

Both FS 209E and ISO 14644-1 assume log-log relationships between particle size and particle concentration. For that reason, there is no such thing as zero particle concentration.

US FED STD 209E cleanroom standards

Class Maximum particles/ft3 ISO equivalent
≥0.1 µm ≥0.2 µm ≥0.3 µm ≥0.5 µm ≥5 µm
1 35 7.5 3 1 0.007 ISO 3
10 350 75 30 10 0.07 ISO 4
100 3,500 750 300 100 0.7 ISO 5
1,000 35,000 7,500 3,000 1,000 7 ISO 6
10,000 350,000 75,000 30,000 10,000 70 ISO 7
100,000 3.5 x 106 750,000 300,000 100,000 700 ISO 8

ISO 14644-1 cleanroom standards

Class Maximum particles/m3 STD 209E equivalent
≥0.1 µm ≥0.2 µm ≥0.3 µm ≥0.5 µm ≥1 µm ≥5 µm
ISO 1 10 2.37 1.02 0.35 0.083 0.0029
ISO 2 100 23.7 10.2 3.5 0.83 0.029
ISO 3 1,000 237 102 35 8.3 0.29 Class 1
ISO 4 10,000 2,370 1,020 352 83 2.9 Class 10
ISO 5 100,000 23,700 10,200 3,520 832 29 Class 100
ISO 6 1.0 x 106 237,000 102,000 35,200 8,320 293 Class 1,000
ISO 7 1.0 x 107 2.37 x 106 1,020,000 352,000 83,200 2,930 Class 10,000
ISO 8 1.0 x 108 2.37 x 107 1.02 x 107 3,520,000 832,000 29,300 Class 100,000
ISO 9 1.0 x 109 2.37 x 108 1.02 x 108 35,200,000 8,320,000 293,000 Room air

Sticky Mat Protocol for Use in Cleanrooms

Shoes on sticky mats
Sticky mats help trap dirt!

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.

Placement

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 employee putting on shoe covers and using a sticky mat

  • 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.

Size

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.

Color

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.

Layer MaintenanceSticky mat with shoes and cart

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.

Installation

  1. 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.
  2. 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.
  3. 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.

Storage

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.

Summary

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.

Importance of Using Shoe Covers

Petri dish with bacteriaHave you ever considered what is on the bottom of your shoes?  Besides things you can see, such as grease, oil, gum, mud, leaves, feces, etc., there are the countless things you cannot see, like germs, bacteria, mold, and viruses.  All of these things walk with us everywhere we go, from the house to the car to the parking lot to the building to the lab or production area to the bathroom to the dining area and back again.  How many other places do we go, like gas stations and public parks, picking up things on our shoes all along the way and transporting them where they are unwelcome?

As a result, many industries and settings require the use of shoe covers to maintain sanitary or sterile conditions, prevent contamination, limit the spread of infections, comply with health codes, etc.  A review of the literature turned up several key findings such as the following:

“In this study, the authors subjected six occupied rodent holding rooms in their animal research facility to three conditions: use of disinfectant mats; use of shoe covers; and no disinfectant mats or shoe covers. The authors took bacterial culture samples from the rooms under each condition. There was no significant difference in the mean number of colony forming units (CFUs) cultured when the disinfectant mats or shoe covers were used. However, the mean number of CFUs obtained was significantly lower when either disinfectant mats or shoe covers were used than when neither was used. These results suggest that using disinfectant mats or disposable shoe covers may reduce the bacterial load on rodent holding room floors.”[1]

“We recommend that gloves and footwear worn by employees who handle RF-RTE foods or who work in areas where RF-RTE are processed or exposed be made of impermeable material, in good repair, easily cleanable or disposable (emphasis added), and used only in RF-RTE areas.”[2]

“Health care workers who handle hazardous drugs are at risk of skin rashes, cancer and reproductive disorders. NIOSH recommends that employers provide appropriate personal protective equipment (PPE) to protect workers who handle hazardous drugs in the workplace…Use hair and shoe covers constructed of coated materials to reduce the possibility of particulate or microbial contamination in clean rooms and other sensitive areas.”[3]

Based on the above, it is clear that using disposable shoe covers is a credible and recommended method in a variety of situations and controlled environments.

[1] Allen KP, Csida T, Leming J, Murray K, Thulin J. Efficacy of Footwear Disinfection and Shoe Cover Use in an Animal Research Facility, U.S. National Library of Medicine, http://www.ncbi.nlm.nih.gov/pubmed/20305633

[2] US Food and Drug Administration, Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods, Section XI, Paragraph IV

[3] Personal Protective Equipment for Health Care Workers Who Work with Hazardous Drugs, https://www.cdc.gov/niosh/docs/wp-solutions/2009-106/pdfs/2009-106.pdf