Pharmacy Market BUZZ

Market News, Products, Services, and Trends

Floor Surface Contamination in Controlled Environments: A Change in Mindset


Objectives

Evaluation argument for contamination control at the floor level

Including the floor level in a holistic view of the contamination control process


The Story 

Studies in the late 1960’s – 1970’s demonstrated that redistribution of bacteria into the air from the floor accounted for up to 15% of all airborne bacteria (Hambraeus et al. 1978) and disinfection alone is short lived given the rapid rate of recontamination on vast surface such as the floor (Ayliffe, 1967).

Current evidence surrounding floors as a key surface discusses how it may act as a reservoir in the chain of infection both in sensitive environments and potentially in other facilities as well.

The 2000’s started to paint a clearer picture of how floor surfaces acted as vectors of re-dispersion for microbes (Gupta, 2007). The evidence consistently points in the direction of floors playing a role in pathogen dissemination, especially dust particles (Prout, 2013). Backing earlier research linking the risk of human shedding issues (Hambraeus, 1978) & their pathogenic risk if airborne (Wei, 2016).

While there is limited research being developed on floor level controls outside of the healthcare setting, it is generalized as a relegated entity within a contamination control practice versus other surfaces.


The Science

The largest surface area in each room is seeing the least control across a variety of industries ….

Touch level and air surface cleanliness alone are not sufficient practices based on the criticality of the areas they are positioned in. At best, one of the most basic requirements in controlled environments, shoe covers,  can themselves be a new vector of concern due to cross contamination between zones.

Define Vectors - A vector is a path for contamination to travel with minimum disruption or control through wheels, shoes and the surfaces as a whole


Picture1.png

More people + more capacity + more activity = more particles + more risk = more control

Most end users spend 80% of budget/time/effort on 20% of a problem when a reversal can yield more sustainable, long-term gains.

Floor level control reduces substantial risk prior to controlled entry in a far more sustainable way.



Picture2.png


The ‘Sense’ 

Cases explored and the Onion.

The five second rule might apply in your kitchen, but it does not apply in sensitive manufacturing.

The following diagrams represent a concept presented by Dr. Tim Sandle, he calls it the onion concept. This concept illustrates the most critical area, the one you want to keep free of contamination at the center of the diagram. This could be a cleanroom, controlled environments, and/or high-care settings. The critical center area is protected by the outer layers (or other areas) that surround it. Certain measures are put in place in these outer layers to prevent contamination from entering the critical area, this can include hand washing, gowning and contamination control flooring. As personnel move through each layer, it becomes cleaner and cleaner until they reach the critical area in the center. Depending on the criticality of the site, it will determine how many layers or areas there are to move through before reaching the center. 

You can see below a diagram of how particles at floor level may travel through each layer, the red particles show the general risk and most contamination comes from the outer layers inwards. The larger particles tend to be prevented earlier on and less particles are transferred as you move through the layers.

A selection of settings where this is applicable...


Cleanrooms
Controlled Environments
High-care Environments

Picture3.png

Picture4.png

Picture5.png

- Require multiple air changes and transfers

  layers of the environment

- Industries – Pharmaceuticals, Medical Device,

  Life Sciences

- ISO – 5 (Sterile) <0/5 microns

- Layered PPE at entry

- Microbial contamination risk to products

- Industries – EV/Automotive, Semiconductors,

   electronics

- Large particle and dust transference issue

- Heavy wheeled traffic in volume

- ESD dissipative requirements at floor level

- Multiple entry points

- Industries – Food, Healthcare, Nutrionals

- Microbial issue at the floor level

- Less layers leading up to the critical zone

- Heavy volume of traffic / frequent shift changes

- Contamination and safety issues in packaging

   areas

- Communal GMP zones

- Light foot traffic


The Suggestion 

Dycem Contamination control flooring alternatives.


Cleanroom Settings


Transfer bays can be tailored at floor level to support pass box entries for wheels between ISO layers. 

Dust particles suspended in air or compressed on wheels are collected and retained 

Airlocks between CNC corridors & Graded Bays require barriers against cross-contamination from inside multi-fill lines.

Dycem is fully customizable to support the optimum use of the space and can even help visually alert a change in protocol.

Picture6.png



Picture7.png



Controlled Settings (Microbial)

Dirty and clean side scenarios put a lot of pressure on cleaning and solutions exist to remove the risk of human error. Positive airflows can help suspended particles carry viable organisms to the floor and be collected if there is something in place to do so.

Fibers, hairs, skin all in highly concentrated actions. If the layer jumps a level, it’s challenging to control without more frequent costs inside vs at source.

Picture8.png

Picture9.png


Controlled Settings ESD


Turnstile entries high in pedestrian volume require conductive contamination control to reduce ESD risk prior to entry. Customizing around other processes at floor level makes control ‘unavoidable’.

Our WorkZones mats are tailored further to focus on the priority and optimize longevity with designs that focus on wheel rotations in packaging/warehouse operations.

Picture10.png

Picture11.png


Hi-Care Settings


Communal pedestrian areas in small spaces create heavy particle dispersion and shedding. In a settled state, most particles linger on the floor and at next shift new vortices are created… solutions to trap and retain in repetitive SOP are of good value.

Incorporated to adapt to pre-existing measures and full circle sanitation procedures. Visually impacting to support behavioral contamination control.

Picture12.png

Picture13.png


The Statement

Moving forward, what influence will floors have on contamination control?

As Floors are a surface of high transmission, the contamination risk merits wider, more comprehensive research to value its part in a contamination control strategy (CCS). Part of this research considers the floor as a priority “vector surface” to allow it to share equal weight in developing a CCS. If floors are treated for particulate control at the source of contamination, they can offer an exhaustive list of benefits for critical and controlled settings. Practitioners of CCS should approach the topic with a more holistic view to develop a CCS as part of their day-to-day, good manufacturing practices (GMP). 

Dycem has vastly improved cross-contamination reduction through its ability to be unavoidable, simple, and a long-term, effective solution.



Today's Posts
Subscribe