The case for multi-pack consumables

"The transfer of materials into and out of the unit is one of the greatest potential sources of contamination" (MCA Rules & Guidance for Pharmaceutical Manufacturers and Distributors 2002). The need for better transfer and disinfection procedures has been highlighted by studies looking into the bioburden on a range of items passed into pharmaceutical isolators1. This work showed that 60% of items ready for transfer were contaminated with bacteria prior to disinfection. More significantly, 40% of items were contaminated with bacterial spores that would not be removed by spraying with alcohol alone (Table 1). Further work was then carried out to assess the effectiveness of different liquid disinfection techniques1 (Table 2). Spraying and wiping was found to be the most effective method of transfer disinfection – especially against spores – because bacteria and spores can create a protective biofilm and therefore require the surface to be agitated by wiping to remove them.

Reduce initial bioburden However, even if a pharmaceutical facility adopts good spray and wipe protocols, there are inherent risks of a high initial bioburden from certain types of packaging. For example, with paper-backed items the paper itself is porous so it can readily accept contamination and it presents an uneven surface that makes wiping less effective. In addition, good practice should always try to limit the amount of paper passed into a cleanroom environment. 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. Multi-packs are double bagged, so that gross contamination can be removed during the first transfer by the removal of the outer bag. 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 particulates Another reason that paper packaging needs to be reduced within a cleanroom is because paper 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 shedding of particles on opening.

Reduce packaging waste Multi-packs eliminate the need for individual packaging and therefore produce significantly less packaging waste. This minimises the space required to store waste items, which can present a problem within the confined space of isolators or laminar flow cabinets. They also minimise environmental impact and can reduce the cost of disposal.

But will it add to the transfer time? Regulatory authorities are demanding better disinfection procedures, usually leading to additional physical wiping. The time taken to spray and wipe 25 individually packed syringes is significantly greater than the time taken to spray and wipe one polythene multi-pack containing 25 loose syringes. Many controlled areas will require at least two transfers, so that time difference is multiplied. If you take into account the additional time savings in counting batches, recording batch codes, opening the packaging and disposing of the packaging, then the multi-pack presents an extremely efficient solution. Independent data from a leading commercial aseptic unit recorded an 86% time saving* for transferring 25 syringes2 (Table 3).

Increase cleanroom capacity There are other compelling reasons for using sterile multi-packs of components. If you look at the data in Table 3 in another way, it shows you could transfer 7.5 times* the volume of components with no extra staff, allowing a significant increase in cleanroom capacity. Since many cleanrooms are already close to efficient capacity, multi-packs can make a positive contribution to both the output of the facility and the more effective deployment of technicians. Multi-packs offer an efficient method of high quality transfer of quantities of sterile components into the controlled workspace. The sterile double-bagged packs contain pre-counted sterile components in a range of quantities such as 5, 10, 25 or 50 in order to reduce the risk of any initial bioburden and mean that only one item needs to be disinfected. The single bag is easier to wipe, enabling more effective spray & wipe protocols to be used. Multi-packs should be produced in a cleanroom environment to GMP standards and gamma irradiated to ensure sterility. They should also be CE marked where appropriate. A wide range of components is available as standard and custom or mixed-pack options can be produced to order. For users of gassing isolators, multi-packs can be provided in vaporised hydrogen peroxide packaging to reduce aeration time and decrease production downtime. Multi-packs are also available in beta bags for direct connection to an isolator port, offering even greater efficiency. EU GMP guidelines state that all items passed into a Class A environment must be sterile3. This includes sharps bins, bags, paper (which must be low shedding and free of binders and chemical additives) and pens (which must have alcohol-fast permanent ink and alcohol-fast printing on the barrel, with low sodium content). All these items are now available double bagged and sterile.

Check your techniques A kit is available that can be used to train technicians in correct disinfection procedures and can also be used for ongoing evaluation of techniques and protocols. The Glo-germ Operator Training Kit uses liquid and powder containing particles that fluoresce under UV light. It is designed for use in the training suite, away from production areas. Simply dust an item such as a paper backed syringe with the powder, spray and wipe according to your protocol and then place the item under the UV light to see whether any particles remain. If some particles fluoresce, this indicates that if there were real contamination on the item it would not be removed and you might need to look again at your procedures, or consider lower-risk items for transfer, such as sterile multi-packs.