Abstract
The regulatory framework of tissue banking introduces a number of requirements for monitoring cleanrooms for processing tissue or cell grafts. Although a number of requirements were clearly defined, some requirements are open for interpretation. This study aims to contribute to the interpretation of GMP or GTP guidelines for tissue banking. Based on the experience of the participating centers, the results of the monitoring program were evaluated to determine the feasibility of a cleanroom in tissue banking and the monitoring program. Also the microbial efficacy of a laminar airflow cabinet and an incubator in a cleanroom environment was evaluated. This study indicated that a monitoring program of a cleanroom at rest in combination with (final) product testing is a feasible approach. Although no statistical significance (0.90 < p < 0.95) was found there is a strong indication that a Grade D environment is not the ideal background environment for a Grade A obtained through a laminar airflow cabinet. The microbial contamination of an incubator in a cleanroom is limited but requires closed containers for tissue and cell products.
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References
Briggs Phillips G (1965) Technical manuscript 260: microbiological barrier techniques. US Army Biological laboratories, Fort Detrick
Buttner MP, Stetzenbach LD (1993) Monitoring airborne fungal spores in an experimental indoor environment to evaluate sampling methods and the effects of human activity on air sampling. Appl Environ Microbiol 59:219–226
Caselli-Fernandez LM, Terkola R (2006) Clean room environment, personnel, quality assurance and their monitoring. Eur J Hosp Pharm Pract 12:29–34
Cobo F, Stacey G, Cortes JL, Concha A (2006) Environmental monitoring in stem cell banks. Appl Microbiol Biotechnol 70:651–662
European Commission (2006) Directive 2006/86/EG implementing Directive 2004/23/EC of the European parliament and of the council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells
European Commission (2008) vol. 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use—Annex 1 Manufacture of Sterile Medicinal Products
European Union (2004) Directive 2004/23/CE of the European parliament and the council of March 31st relating to the establishment of quality and safety norms to donate, to obtain, to assess, to process, to preserve, to store and to distribute human cells and human tissues
Favero MS, Puleo JR, Marshall JH (1966) Comparative levels and types of microbiological contamination detected in industrial cleanrooms. Appl Microbiol 14(4):540–551
Herlong JL, Reubish K, Highdon HL III, Boone WR (2008) Quantitative and qualitative analysis of microorganisms in an assisted reproductive technology facility. Fertil Steril 89(4):847–853
Holbrook D (2010) Controlling contamination: the origins of cleanroom technology. Hist Technol 25(3):173–191
ISO 14698:2003 Cleanrooms and associated controlled environments—Biocontamination control
Kuster E (1915) Die gewinnung, halting und aufzuche keimfreier tiere and ihre bedeutiung fur die erforschung naturlicher lebersvorgange. Arb Kaierl Gesundh 48:1–79
Langstrom B, Hartvig P (2007) GMP, three letters with many interpretations. Eur J Nucl Med Mol Imaging 35(4):693–694
Nelson CL, Greenwald AS (1973) Clean air and total hip arthroplasty. Clevel Clin Q 39(3):101–107
Pasquarella C, Pitzurra O, Savino A (2000) The index of microbial air contamination. J Hosp Infect 46:241–256
PDA (2001) Fundamentals of an environmental monitoring program. Technical report no. 13. J Pharm Sci Technol 55(5):1–35
Ritter M, Schwedler J, Beyer J, Movassaghi K, Mutters R, Neubauer A, Schwella N (2003) Bacterial contamination of ex vivo processed PBPC products under cleanroom conditions. Transfusion 43:1587–1595
Schicht H (2006) Regulatory guidance for manufacturing sterile pharmaceutical products—recent EC and FDA developments, bioprocess and biopartnering. Touchbriefings, London, pp 42–44
Slopecki A, Smith K, Moore S (2007) The value of good manufacturing practice to a blood service in managing the delivery of quality. Vox Sang 92:187–196
Stucki C, Sautter AM, Favet J, Bonnabry P (2009) Microbiological contamination of syringes during preparation: the direct influence of environmental cleanliness and risk manipulations on end-product quality. Am J Health Syst Pharm 66:2032–2036
United States Pharmacopeia 29 (2005) <1116> Microbiological evaluation of cleanrooms and other controlled environments. USP29-NF24 p2969
Whitfield WJ (1966) Microbiological studies of laminar flow rooms. From annual convention of the parenteral drug association, New York. UNCL. Orig. Report no SC-DC-66–2277
WHO (2011) Environmental monitoring of cleanrooms in vaccine manufacturing facilities. Eight Draft, 27 February 2011
Wilson J (2001) Environmental Monitoring: misconceptions and misapplications. J Pharm Sci Technol 55(3):185–190
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Klykens, J., Pirnay, JP., Verbeken, G. et al. Cleanrooms and tissue banking how happy I could be with either GMP or GTP?. Cell Tissue Bank 14, 571–578 (2013). https://doi.org/10.1007/s10561-012-9355-8
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DOI: https://doi.org/10.1007/s10561-012-9355-8