Development of a validation protocol to determine the ability of screw-top containers to be watertight and to withstand
- PDF / 176,424 Bytes
- 7 Pages / 547.087 x 737.008 pts Page_size
- 52 Downloads / 182 Views
Development of a validation protocol to determine the ability of screw-top containers to be watertight and to withstand impact damage from accidental dropping M. J. Eagle Æ P. Rooney Æ J. N. Kearney
Received: 26 February 2007 / Accepted: 11 April 2007 / Published online: 25 May 2007 Ó Springer Science+Business Media B.V. 2007
Abstract Polypropylene screw-top containers are used to collect, transport and store a variety of tissues within tissue banks. These containers are validated for use by tissue banks but no standard validation protocol is used. We present here a protocol for testing screw-top containers for leakage, evaporation and the ability to withstand accidental impact damage. Three different containers were tested, MedFor S072, MedFor S277 and MacoPharma PROT0483. The validation can detect differences between different manufacturer’s containers and this protocol will be used in future validations of screw-top containers within National Blood Service Tissue Services. Keywords Polypropylene container Drop test Leak test Evaporation test Introduction Several kinds of human donor tissue are stored and transported in double polypropylene container units comprised of a smaller inner container which fits inside a larger outer container. The use of double container units is specified in the Guidelines for the Blood Transfusion Services in the United Kingdom M. J. Eagle (&) P. Rooney J. N. Kearney Tissue Development Laboratory, National Health Service Blood and Transplant, National Blood Service Tissue Services, Estuary Banks, Speke, Liverpool L24 8RB, UK e-mail: [email protected]
(Red Book, 2005). National Blood Service Tissue Services (TS) uses such containers to collect, store and transport femoral head bone, in a frozen state and skin in a fresh state. In addition, a large part of the skin processing procedure is also carried out with the tissue in the polypropylene container. Approximately 6000 double container units are used by TS each year. Tissue banking is covered by quality standards both nationally (British Association for Tissue Banking, General Standards 2006; Dept. of Health Code of Practice 2004) and internationally (European Association for Tissue Banking, Standards 2006) and containers are required to be CE marked (European Union, Medical Device Directive 93/42/EEC). Double containers must be used for tissue which is going to be frozen (Red Book, 2005, Villalba et al. 2004). The container should be large enough to hold the tissue, it should be watertight, it should be able to withstand low temperatures (if applicable) and it should be able to withstand accidental dropping (Villalba et al. 2004). As part of Quality Control procedures, TS regularly validates existing products and processes to ensure that they are up to date and provide tissue fit for purpose. In this report, we develop and describe a validation protocol which tests screw-top containers for leakage, evaporation and the ability to withstand accidental dropping, whilst frozen and at ambient temperature, onto a standard s
Data Loading...
