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

Seven Reasons to Utilize Revolutionary Automatic Shoe Cover Dispensers and Removers

There are multiple methods for businesses and organizations to keep their facilities clean and minimize or prevent contamination from the wide variety of contaminants that exist on shoes.  The four most prevalent options are shoe covers/booties (disposable or reusable), dedicated/facility shoes, sticky/tacky mats, and chemical baths.  The relative pros and cons of these will be discussed in a future blog post.  This blog post focuses on shoe covers and a revolutionary technology for putting them on and taking them off.

Shoe covers are essential in many applications for keeping environments clean and free from contamination.  In some cases, you want to prevent whatever is on the floor from getting on your shoes.  Other times you want or need to prevent contaminants on your shoes from getting on the floors in your environment for maintenance and sanitation, health and safety, infection control and other reasons.  In the past people had to apply and remove their shoe covers manually, but this is time-consuming, can be dangerous, and is definitely not clean.  Alternatively, many entities are now utilizing automatic shoe cover dispensers and removers to address these issues.  Here are seven reasons why:

  • Speed: it’s faster

No bones about it, putting shoe covers on the old-fashioned way is time-consuming – the entire process, which includes grabbing a pair of shoe covers and finding a place to put them on, easily takes somewhere between 30 and 45 seconds each and every time.  Removing them can take even longer, especially in an environment that requires more extensive hygiene practices.  With Shoe Inn’s revolutionary automatic shoe cover dispensers and removers, the time is reduced to about five (5) seconds!

  • Efficiency = productivity = $$$

Applying shoe covers faster and more efficiently means employees can get to work faster. The Shoe Inn system makes the process of applying and removing shoe covers AT LEAST four times (4x) faster.  This significantly shorter gowning time equals increased efficiency that translates to increased productivity, meaning you are not wasting money paying your employees to put on shoe covers but instead are paying them in their work environment where they are being productive. Cumulatively, these small time saving increments add up to big savings for your business!

  • Easy breezy

Putting shoe covers on is easy for some people, a walk in the park.  However, for others it can be a real challenge for a variety of legitimate reasons. Many, many times we’ve been told by people at tradeshows (with colorful, choice words) how much they despise, detest, even flat out refuse to put shoe covers on.  Employ automatic shoe cover dispensers, which make it so much easier to put booties on, and those challenges and objections will vanish, thereby increasing compliance.  Same goes for the remover, just at the back end of the process.

  • Safety rules

Automatic shoe cover dispensers and removers keep employees and visitors safer by iStock_000020353612Largereducing the risk of injuring themselves while putting shoe covers on and taking them off.  Instead of bouncing around while attempting to balance on one foot and lifting the other leg, which we have dubbed the “bootie hop” (see The Bootie Hop video), people can safely apply and remove their shoe covers in an ergonomically friendly manner.  The handlebars found on the Shoe Inn Stay dispenser and both ASCR removers make it even safer and easier.  Say goodbye to those workers’ comp claims!

  • It’s cleaner

Open hand raised, Stop Bacteria sign painted, multi purpose concPutting shoe covers on and taking them off by hand is dirty business.  Your shoes, particularly the bottoms, are gross – just think about everything you’ve stepped in and on while walking around streets, parking lots, subways, parks, trails, public bathrooms, etc.  It is almost inevitable that you’re going to touch your shoes while putting shoe covers on manually and thus contaminate your hands.  Depending on the environment, used shoe covers can be soiled as well so automatic shoe cover removers do the dirty work for you.

  • Save precious space

Oftentimes wherever shoe covers need to be put on and/or taken off, space is at a Cleanroom employee putting on shoe covers and using a sticky matpremium.  Gowning benches and chairs take up space and can be obstructions.  Shoe cover dispensers and removers take up much less space, especially proportionately when factoring in how much more efficient they are in facilitating people getting through the process.  Fewer benches and chairs mean more space for other necessities.

  • Dressed to impress

Starward-virtual-proof-2Manually putting shoe covers on and taking them off is so old school.  While there will always be a place for doing certain things the old-fashioned way, why not look professional and impress your customers, visitors, regulators, inspectors and auditors?  In fact, you can customize your Shoe Inn dispensers and removers with your corporate logo, motto/slogan, contact information, etc. to further cement your brand.

As you can see, there are many benefits to implementing an automatic shoe cover dispensing and removal system.  Want to know more?  Check out our line of shoe cover dispensers, shoe covers and removers or contact us.  At Shoe Inn, we make putting shoe covers on and taking them off faster, easier, safer and cleaner!

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.

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