The Evidence Tests were
The Evidence Tests were carried out in the DWS GLP compliant laboratories on the use of the Whitley HEPA Filtration System within an anaerobic chamber. Two Whitley Workstations were used - one fitted with HEPA filtration, one without HEPA. These tests demonstrated that the system produces a rapid and substantial reduction in bacterial contamination of the atmosphere. Atmoshpere was sampled from three locations - the chamber interior, the location adjacent to the pressure relief valve outlet, and the external atmosphere adjacent to the chamber (in the operator’s position). The results confirmed that no bacterial colonies were recovered from any of the sampling points after 2 minutes of the introduction of bacteria by nebulization. The full results of these experiments are shown in the adjacent tables and the paper can be found on our website under Whitley A35 downloads. Potential uses of a Whitley HEPA Filtered Workstation: Use of anaerobic culture as part of a pharmaceutical manufacturing process, which would ideally be conducted under “cleanroom” conditions, ie the growth or manipulation of anaerobes used to produce a vaccine or pharmaceutical preparation. Table 1: Recovery of K. rhizophila colonies from standard anaerobic chamber (No HEPA) Before nebulization 0 0 Before nebulization During nebulization (1.9x10 8 cfu / 5 min) ≥258 ≥258 During nebulization (1.2x10 8 cfu / 5 min) 0 ≥258 ≥258 0 2 min ≥258 ≥258 2 min After nebulization 5 min ≥258 ≥258 5 min 10 min ≥258 ≥258 10 min After nebulization Table 2: Recovery of K. rhizophila colonies from HEPA filtered anaerobic chamber Before nebulization 0 0 Before nebulization During nebulization (2.1x10 8 cfu / 5 min) ≥258 0 During nebulization (1.2x10 8 cfu / 5 min) 0 55 0 0 2 min 2 0 2 min After nebulization 5 min 0 0 5 min 10 min 0 0 10 min After nebulization Table 3: Recovery of C. beijerinckii colonies from HEPA filtered anaerobic chamber Before nebulization During nebulization (3.3x10 5 cfu / 5 min) 0 232 8 0 After nebulization Table 4: Recovery of K. rhizophila colonies from operator's position (No HEPA) Before nebulization During nebulization (1.9x10 8 cfu / 5 min) 15 min ≥258 ≥258 15 min 15 min 15 min 20 min ≥258 ≥258 20 min 20 min 20 min 2 min 5 min 10 min 15 min 20 min 0 0 0 0 ≥258 ≥258 HEPA 30 min 30 min 30 min 0 0 HEPA 30 min 0 0 0 0 0 0 After nebulization HEPA 30 min 0 2 min 5 min 10 min 15 min 20 min 30 min 0 ≥258 ≥258 ≥258 ≥258 ≥258 ≥258 ≥258 ≥258 HEPA HEPA Filtration/007-01/July 2014 Cultivation of slow-growing anaerobes: HEPA filtration would reduce the risk of contamination by faster growing strains. Applications requiring complex manipulations under anaerobic conditions (for example, biochemical assays) where anaerobe cultures may be open to the ambient atmosphere for an extended period. HEPA filtration would reduce the risk of contamination under these conditions. • Cancer Research • Neurology • Cardiovascular research • Stem cell work and many other types of cell culture work Table 5: Recovery of K. rhizophila colonies from operator’s position (HEPA) Before nebulization During nebulization (1.2x10 8 cfu / 5 min) After nebulization 0 2 min 5 min 10 min 15 min 20 min 30 min 0 0 0 0 0 0 0 0 0 Numbers of colonies recovered are all from 100 litre air samples / Upper detection limit for air sampler = 258 colonies A07040 Whitley A35 HEPA Workstation 240V A07041 Whitley A35 HEPA Workstation 110V A06060 Whitley H35 HEPA Hypoxystation 240V A06061 Whitley H35 HEPA Hypoxystation 110V A06050 Whitley H45 HEPA Hypoxystation 240V A06051 Whitley H45 HEPA Hypoxystation 110V In the interests of a policy of continuous product improvement the company reserves the right to alter product specifications without prior notice. All rights reserved. © 2014 Don Whitley Scientific Ltd. HEPA Models Available Don Whitley Scientific Limited 14 Otley Road, Shipley, West Yorkshire, BD17 7SE, England. Telephone: +44 (0)1274 595728 Fax: +44 (0)1274 531197 Website: www.dwscientific.co.uk Email: info@dwscientific.co.uk
