Improving the aseptic transfer procedures in hospital pharmacies part C: evaluation and redesign of the transfer process

Abstract

Objectives To transfer sterile medical devices (SMD), infusion bags (IB), ampoules (A), injection vials (V) and infusion bottles (B) into a laminar airflow cabinet (LAF) or safety cabinet (SC) with a surface bioburden as low as possible. Methods Surface bioburden of the outer layer of SMD, IB, A, V and B was determined by contact plates. Surface bioburden determination of critical spots on A, V and B (ampoule necks and stoppers) was determined by high-recovery swabs and contact plates. Particle emission from white cardboard boxes was determined by a particle counter. Results The chances of a contaminated outer layer of SMD is negligible as long as they stay in their original boxes. The outer layer of double-packed IB can contain a considerable number of micro-organisms. As found in previous studies, the surface bioburden of A, V and B is low as long as they stay in their original cardboard boxes. Particle emission from white boxes is low. The necessity of a final disinfection step inside LAF/SC of critical sspots of A, V and B cannot be proven. SmallSMD, ampoules and injection vials can be transferred into the background areain their original white boxes. Other materials have to be unpacked in front ofthe lock while the operator wear disposable gloves. Disinfection of the outerlayer of IB, before transfer trough the lock, is advised. Tohave materials with a low chance of contamination in LAF/SC, transfer bypresentation for SMD and IB and using a sterile tray for disinfected materialsis an effective procedure. Wiping of ampoule necks and stoppers inside LAF/SC isadvised based on risk assessment. Small SMD, ampoules and injection vials can be transferred into the background areain their original white boxes. Other materials have to be unpacked in front ofthe lock while the operator wear disposable gloves. Disinfection of the outerlayer of IB, before transfer trough the lock, is advised. Conclusion When SMD, ampoules, injection vials and infusion bottles stay in their original boxes as long as possible, the aseptic transfer and the disinfection procedure can be maintained effectively and efficiently.

Reducing the risk of non-sterility of aseptic handling in hospital pharmacies, part B: risk control

“…The additional risk reduction for materials with a sterile surface, as described in figure 3 , are in accordance with the recommendations in a previous article. 5 The multidisciplinary team considered the application of a sterile pad (see Boom et al 5 ) as an important risk reducing measure (occurrence reduced by 2 points) which can be detected easily (detection reduced by 1 point).…”

“… 1 Keeping ampoules and vials in their original boxes as long as possible and handling these materials with gloved hands can mean a low bioburden before disinfection. 5 These measures are easy to detect and therefore will reduce occurrence and detection.…”

“…Additional disinfection of critical spots (E2) in the LAF/SC cannot be validated by microbiological investigations. 5 This makes the importance of auditing, and operators who correct each other, even greater. However, the remaining risk of non-sterility caused by needle or spike contact with critical spots of vials and ampoules has to be accepted ( figure 3 ).…”

Reducing the risk of non-sterility of aseptic handling in hospital pharmacies, part C: applying risk assessment and risk control in practice

“…Therefore, a sterile pad is advised to prevent contact between critical spots (syringe tips, needles, openings of tubes) and the surface of the worktop. 12 By the end of the study this pad was being used in four hospital pharmacies (see table 2). An alternative is to put syringes and needles on a sterile holder.…”

“…This way of working keeps the surface bioburden of ampoules and vials low and shows no measurable influence on the particle burden in the background area. 12 Application of risk assessment can also cast doubt on habits that have become general practice after years and years. For example, in previous articles we made clear that viable air sampling inside LAF/ SC is not sensitive enough for controlling the environment inside LAF/SC or for detecting a filter failure.…”