Keeping Cardboard Out of Your Cell Processing Facility

This post is part of our Inspection Readiness series.

One of the most common issues that I see as an assessor has a really easy solution -  keeping all of the cardboard out of your processing facility.

Even in modern Cell Processing Facilities, I still see cardboard boxes, which is always a surprise as this is specifically against the  Joint Commission’s stance on cardboard in sterile processing areas. Yes, the inside of your biological safety cabinet is your sterile processing area, and the cardboard may be on a shelf or in a cabinet, but do you really want to argue with the Joint Commission inspector? Also, most Universities have prohibitions against storing items in cardboard boxes in cold rooms. While it may not seem to be such a big thing, your best bet is to remove it from your lab/processing facility entirely.

Cardboard is a source of two kinds of live contamination - 

• Microbial

• Vermin (rodents, insects and possibly lizards - this happened to me at my house! Oh Florida.)

You’re really introducing unknown contaminants into your carefully controlled facility. Those boxes have been in a warehouse, on a loading dock, in trucks, exposed to weather, pollen and dust, tossed around by your delivery person, placed on another loading dock and finally delivered to your lab through the receiving department - probably on a wheeled cart. If you want to surprise someone who is resistant to removing all of the cardboard from the lab, take them to the loading dock and show them the journey to your facility. You can always do a culture swab on the wheels of that cart - it has been everywhere around the hospital. 

Cardboard cannot be decontaminated with a surface spray, so forget about trying to spray it into compliance. The disinfectant cannot soak through the entire box and still have it maintain its structural integrity (you’ll have a soggy pile of wood pulp). The outside of the cardboard is potentially covered in dust from its trip from the manufacturing site, but cardboard is itself a source of particle contamination. If the box is not properly opened - there is the potential for the box to be the source of additional particulates - and even using a knife or boxcutter may not be effective. If you want to try a fun experiment or two, try running your particle counter or open up a settle plate while opening boxes.

If you cannot avoid having cardboard in your lab there are several things that you should do -

• Keep the boxes as far away from the processing area as possible

• Store the cardboard boxes in plastic totes until the box will be used

• Perform a risk assessment  - The Joint Commission says to ‘consider the potential adverse impact of dust, moisture, bacteria or other contaminants on that area.” At least you’ll have documentation that you considered the risk. Also document any decisions made as part of the risk assessment activity.

You should also have a copy of your institution's pest policy (required by 21 CFR 211) and be able to state how often your area is monitored and treated for bugs and rodents and also be able to show where the rodent traps are located.

Some of my recommendations are: 

• Define a receiving area for supplies and reagents far from the processing area

• Identify an unpacking area that is not the exact location as the receiving area (some sites will mark a countertop with tape to indicate where outside boxes are to be placed.)

• Determine what types of containers are allowable for transfer of consumables from the shipping container to lab storage

• The container it comes in - such as pipette tips - may be okay once out of the cardboard

• Plastic shoe bins or emesis basins are fine, but the plastic tends to be soft and scratchable, so this may not be the best solution

• Akrobins, with or without the lids, are durable and come in a variety of sizes. They are easily cleanable and can be wiped with 70% alcohol

• Clear plastic containers, such as the ones from major retail centers, come in a variety of sizes. 

• Wire steel shelving units on castors are great for keeping the area clean - dust falls to the floor rather than accumulating on solid shelves. Sweeping and mopping schedules should be maintained. Castors should be wiped as part of the scheduled cleaning as the wheels tend to accumulate dust and debris.

• Zip-top style bags can also be used, but you may want to consider them a single-use disposable

A few final tips to make any inspection go smoother

• Using a label maker with a template allows for consistent labeling of the containers. When I am inspecting a site, and I see that the materials are in a state of control, it gives me confidence that other areas of the lab are also in a state of control. If I walk into a supply area and it is a jumbled mess, I’m going to groan inwardly and assume that everything else is a mess - because if you are immune to seeing your physical mess, you are probably also immune to seeing your documentation mess.

• Line up the bins, boxes and totes as if you were working late night at a grocery store. Everything is straight and at right angles. Again, state of control - the appearance of control is absolutely critical during a tour and my first impression is going to inform the rest of my inspection.

• Have someone else look at your lab a week before an inspection. A pair of fresh eyes can be really helpful, especially if they know what to look for in advance. Have them perform a mock inspection with a checklist.

Note that you should always recycle cardboard where possible and in some jurisdictions, it is illegal to dispose of it down a drain or sewer.