Materials brought in and out of controlled environments is a major source of contamination. There are ways to reduce the initial bioburden on items passed into the cleanroom, so that contamination is minimized. This includes:
Using the most effective disinfection technique
Reducing the number of paper packed items
Reducing the amount of packaging that needs to be disinfected, by bulk packing items such as syringes, needles, and waste bags
Ensuring the disinfectant used stays sterile and does not cause contamination
Use Effective Disinfection TechniquesEU GMP (European Union Good Manufacturing Practices) Annexe 1 states that “The transfer of materials into and out of the unit is one of the greatest potential sources of contamination.”
Reducing Initial BioburdenHowever, even if a hospital clean-room adopts good spray and wipe protocols, there are risks of high initial bioburden from certain types of packaging. For example, the paper in paper-backed items is porous so it is easily contaminated and the uneven surface makes wiping less effective.
An effective solution is to use a sterile multi-pack that contains a quantity of sterile components, removing the need for individual packaging. The smooth polythene bag of a sterile multi-pack is easy to wipe and does not support the presence of bacteria in the same way as paper.
Many components required in the cleanroom are difficult to spray and wipe, due to their small size or awkward shape. Again, the multi-pack bag is easier to wipe effectively.
Reduce ParticulatesPaper packaging also needs to be reduced within a cleanroom environment because it carries a high particulate load. The number of particles shed is so great that if you open 50 paper-backed syringes over a dark surface you can easily see the shed particles on the surface. By contrast, the polythene multi-pack bag virtually eliminates the shedding of particles on opening.
Reduce Packaging WasteMulti-packs eliminate the need for individual packaging and therefore produce significantly less packaging waste. This minimizes the space required to store waste items within the confined space of isolators or laminar flow cabinets