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Manufacturing Practice (manufacturing + practice)
Kinds of Manufacturing Practice Selected AbstractsSURVEY OF APPLE GROWING, HARVESTING, AND CIDER MANUFACTURING PRACTICES IN WISCONSIN: IMPLICATIONS FOR SAFETYJOURNAL OF FOOD SAFETY, Issue 2 2000HEIDI E. ULJAS ABSTRACT To evaluate the safety of current apple growing, harvesting and cider manufacturing practices in Wisconsin, cider manufacturers were contacted in a three-phase survey. Results revealed that seasonal, small-scale production was characteristic of the industry. Most cider mills produced less than 5,000 gal/year; only 6% produced more than 20,000 gal/year. Most cider makers used only tree picked apples (86%), inspected apples before washing (94%), washed (93%) and brushed (87%) apples, but only 16% of mills sanitized washed apples. Most mills (92%) sanitized cider making equipment after each use; however, only a few sanitized between custom pressing apples from different customers. Respondents reported that they strived to improve cider safety by pasteurization (43% of all cider), UV light treatment (4%), use of preservatives (30%), and HACCP (17%). For 31% of all cider, however, processors relied solely on refrigeration and/or freezing. These results show that most cider mills practice many steps believed to enhance cider safety, but results also identify procedures that must be addressed to further improve cider safety. [source] Levels of quality management of blood transfusion services in EuropeISBT SCIENCE SERIES: THE INTERNATIONAL JOURNAL OF INTRACELLULAR TRANSPORT, Issue 1 2008C. Seidl The European blood legislation has defined several key quality elements to achieve Good Manufacturing Practice (GMP) in the field of blood transfusion. During the recent years, the blood legislation is in the process of implementation throughout its member states. Following the Directive 2002/98/EC, Directive 2005/62/EC has given further requirements for quality-management systems to be fulfilled by blood establishments. In addition, GMP/Good Laboratory Practice (GLP) and ISO standards are used inter alia by blood establishments. In order to support the implementation of the blood legislation, the European Public Health Work Plan (2005/2007) has cofunded two projects, led by the German Red Cross and supported by the European Blood Alliance, delivering a common European Standard Operating Procedure (SOP) methodology (EU-Q-Blood-SOP) and criteria and standards for the inspection of blood establishments (EUBIS). The EU-SOP manual will assist blood establishments in preparing for the inspection of their services related to the implementation of quality relevant elements required by the EU Directive 2002/98/EC and its technical annexes. The standards and criteria for inspection of blood establishments will cross-reference existing quality standards to the directive requirements and define requirements for the structure of quality-management systems based on the directive 2002/98/EC and its technical annexes. Based on these requirements, inspection standards and criteria are developed to assist in the independent assessment of quality systems established by individual blood establishments. These assessments are done in relation to the requirements defined by the European Union legislation on blood, in order to safeguard the quality of blood and to achieve continuous improvement of its quality throughout Europe. [source] Oxygen infusions (hemoglobin-vesicles and albumin-hemes) based on nano-molecular sciences,POLYMERS FOR ADVANCED TECHNOLOGIES, Issue 2-3 2005Professor Eishun Tsuchida Abstract Since the discovery of a red-colored saline solution of a heme derivative that reversibly binds and releases oxygen (1983), significant efforts have been made to realize an oxygen infusion as a red cell substitute based on the sciences of both molecular assembling phenomena and macromolecular metal complexes. The authors have specified that hemoglobin (Hb)-vesicles (HbV) and recombinant human serum albumin-hemes (rHSA-heme) would be the best systems that meet the clinical requirements. (A) Hb is rigorously purified from outdated, donated red cells via pasteurization and ultrafiltration, to completely remove blood type antigen and pathogen. The HbV encapsulates thus purified concentrated Hb solution with a phospholipid bimolecular membrane (diameter, 250,nm,), and its solution properties can be adjusted comparable with blood. Surface modification of HbV with a water-soluble polymer ensures stable dispersion state and storage over a year at 20°C. In vivo tests have clarified the efficacy for extreme hemodilution and resuscitation from hemorrhagic shock, and safety in terms of biodistribution, metabolism in reticuloendothelial system (RES), clinical chemistry, blood coagulation, etc. The HbV does not induce vasoconstriction thus maintains blood flow and tissue oxygenation. (B) rHSA is now manufactured in Japan as a plasma-expander. The rHSA can incorporate eight heme derivatives (axial base substituted hemes) as oxygen binding sites, and the resulting rHSA-heme is a totally synthetic O2 -carrier. Hb binds endothelium-derived relaxation factor, NO, and induces vasoconstriction. The rHSA-heme binds NO as Hb does, however, it does not induce vasoconstriction due to its low pI (4.8) and the resulting low permeability across the vascular wall (1/100 of Hb). A 5%-albumin solution possesses a physiologic oncotic pressure. Therefore, to increase the O2 -transporting capacity, albumin dimer is effective. Albumin dimer can incorporate totally 16 hemes with a regulated oncotic pressure. The rHSA-heme is effective not only as a red cell substitute but also for oxygen therapeutics (e.g. oxygenation for tumor). Significant efforts have been made to produce HbV and rHSA-heme with a facility of Good Manufacturing Practice (GMP) standard, and to start preclinical and finally clinical trials. Copyright © 2005 John Wiley & Sons, Ltd. [source] Validation of commercial computerised systems using a single life cycle document (integrated validation document)QUALITY ASSURANCE JOURNAL, Issue 2 2009R. D. McDowall Abstract A risk-based approach to the validation of low risk commercially available computerised systems is described. To determine if validation is required, the business process automated by the system is assessed to see if it is regulated. If validation is required, then the Good Automated Manufacturing Practice (GAMP) software category is mapped against the impact of the records generated by the system to determine if full or reduced validation is required. If reduced validation is indicated, the use of a single integrated validation document is proposed and illustrated with two case study examples. The use of a Validation Master Plan (VMP) to facilitate this validation process is also presented and described. Copyright © 2009 John Wiley & Sons, Ltd. [source] Management tools for the evaluation of compliance and costs in the production of chemical,pharmaceutical companiesQUALITY ASSURANCE JOURNAL, Issue 3 2005Franziska Rank Abstract Due to the stringent and increasingly demanding Good Manufacturing Practice (GMP) and customer requirements, companies within the chemical,pharmaceutical sector share the enormous challenge of evaluating and measuring compliance and costs. The need for implementing a compliance measuring tool for production was identified within the Schering AG and activities were undertaken. The established compliance evaluation system and the first model for a compliance cost system proved to be well-structured and suitable for the production. Consequently, the systems can be adapted by other areas and chemical,pharmaceutical companies and may even be expanded to other areas, such as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). Copyright © 2005 John Wiley & Sons, Ltd. [source] Manufacturing Practices and Strategy Integration: Effects on Cost Efficiency, Flexibility, and Market-Based PerformanceDECISION SCIENCES, Issue 3 2005Morgan Swink ABSTRACT Manufacturing plant managers have sought performance improvements through implementing best practices discussed in World Class Manufacturing literature. However, our collective understanding of linkages between practices and performance remains incomplete. This study seeks a more complete theory, advancing the idea that strategy integration and enhanced manufacturing capabilities such as cost efficiency and flexibility serve as intermediaries by which practices affect performance. Hypotheses related to this thesis are tested using data from 57 North American manufacturing plants that are past winners and finalists in Industry Week's"America's Best" competition (Drickhamer, 2001). The results suggest that strategy integration plays a strong, central role in the creation of manufacturing cost efficiency and new product flexibility capabilities. Furthermore, strategy integration moderates the influences of product-process development, supplier relationship management, workforce development, just-in-time flow, and process quality management practices on certain manufacturing capabilities. In turn, manufacturing cost efficiency and new product flexibility capabilities mediate the influence of strategy integration on market-based performance. These findings have implications for practice and for future research. [source] Complaint handling in pharmaceutical companiesQUALITY ASSURANCE JOURNAL, Issue 1 2007Glaucia Karime Braga Abstract Complaints show customer dissatisfaction about the quality of a pharmaceutical product. Despite a regulatory obligation in several countries, a good complaint handling system gives the company an opportunity to improve the quality of their products, being a good tool for the maintenance of Good Manufacturing Practices and a way to establish a committed relationship with their customers. A systematic procedure must be developed and implemented in order to register and investigate each complaint received and not only the Quality Assurance area must be involved. This process must involve other critical areas such as Marketing, Production, Quality Control, Finance, Regulatory and Legal Affairs. Thus the aim of this article is to discuss the main steps of a good complaint handling procedure that can be readily implemented in pharmaceutical companies. Copyright © 2007 John Wiley & Sons, Ltd. [source] Good practice in plasma collection and fractionationISBT SCIENCE SERIES: THE INTERNATIONAL JOURNAL OF INTRACELLULAR TRANSPORT, Issue n1 2010C. Schärer The control strategy to ensure safety of blood products includes a combination of measures focusing on ensuring the quality and safety of starting material by careful donor selection and testing strategies at different levels, together with validated manufacturing processes, including steps to inactivate or remove potential contaminating agents. Using an approach based on good manufacturing practice (GMP) provides a manufacturing model that allows for a documented system of incorporating quality throughout the entire manufacturing process and describes the activities and controls needed to consistently produce products that comply with specifications and are safe for use. There are no doubts that the aim of providing safe and high-quality product to the patients should be the same for all products derived from human blood, independent of its use either as a blood component for direct transfusion or as industrially manufactured product. It would be difficult to justify whether for blood components the good practice standards and for plasma derivatives the GMP standards for manufacturing would not ensure equivalent levels of quality and safety. To ensure a high level of quality and safety of blood components and plasma derivatives, the implementation of double standards in blood establishments and fractionation industry would not be effective and should be avoided. Harmonized standards and good practices for collection and fractionation, based on the principles of GMP, should be envisaged in the whole chain of manufacturing blood components and plasma derivatives. Global initiatives to further promote the implementation of harmonized GMP for the collection in blood establishments and a stringent regulatory control are ongoing. This would further contribute to the global availability of plasma-derived medicinal products. [source] Systems for accreditation in blood transfusion servicesISBT SCIENCE SERIES: THE INTERNATIONAL JOURNAL OF INTRACELLULAR TRANSPORT, Issue 1 2009S. Hindawi Accreditation is a non-governmental, voluntary process that evaluates institutions, agencies, and educational programs. It is defined as the process whereby an agency or association grants public recognition to Institutes or Blood Banks for having met certain established standards as determined through initial and periodic evaluations that usually involve submitting a self-evaluation report, site inspection by a team of experts, and evaluation by an independent board or commission. To be accredited Institution and or Blood Transfusion Services should establish and maintain quality systems involving all activities that determine the quality policy objectives & responsibilities taking into account the principles of good manufacturing practice (GMP). There are many Established systems for accreditation which can help any institution to know its strengths, weaknesses and opportunities through an informed review process. Any assessment and subsequent accreditation is made with reference to a set of standards so that the standing of an institution can be compared with that of other similar institutions. In summery the accreditation is a continuous process for improvement of quality and safety of participating institutes or facilities and we should encourage all health institutes to be involved in one or another system for accreditation. There is a need for a local or regional accreditation system for health institutes especially for blood transfusion services to help in the development and improvement of the quality of their services. [source] European best practice in blood transfusion: improvement of quality-related processes in blood establishmentsISBT SCIENCE SERIES: THE INTERNATIONAL JOURNAL OF INTRACELLULAR TRANSPORT, Issue 1 2007Christian Seidl Transfusion medicine is an expanding field comprising the interaction between several medical disciplines. Looking at the ,vein to vein process' covering the donation of blood by the voluntary donor up to the application of blood components to patients, modern blood transfusion services comprise a large variety of sociomedical functions. The production of standard cellular blood components, such as erythrocyte and thrombocyte concentrates, plasmatic blood components as well as special cellular components such as blood stem cells, mesenchymal cells or granulocytes will require an extensive laboratory testing repertoire to monitor product quality and safety. The European blood legislation has defined several key quality elements to achieve good manufacturing practice in the field of blood transfusion. In addition, GMP/GLP and ISO standards are used inter alia by blood establishments. Following the call for proposal in the field of public health by the European Commission, a consortium of blood establishments from 16 European member, acceding and EFTA states has been established in order to survey the individual quality management systems used by the participants and to developed guidelines for quality systems. These guidelines are aimed at assisting blood establishments in preparing for government inspections as required by Directive 2002/98/EC. They could also be used to adapt existing procedures to comply with current EU requirements and/or to prepare for accreditation and certification of these institutions. Major benefits from those quality management systems are (1) the definition of an overall quality policy, (2) improved personnel responsibility, qualification and training, (3) error and risk assessment system, (4) continuous improvement, (5) improved resource management, (6) performance improvement. The definition of cost,benefit relation between certification and accreditation of blood establishments will depend on the individual institution itself and the amount of processes covered. With the release of the new EU Directive 2005/62/EC, there are currently EU requirements available that describe in detail relevant processes to be covered by quality system following good practice used in blood establishments. A future challenge for transfusion medicine would be optimizing the synergetic effects expressed by the EU directive, GMP and ISO standards. [source] Closed system generation of dendritic cells from a single blood volume for clinical application in immunotherapy,JOURNAL OF CLINICAL APHERESIS, Issue 4 2005M. Elias Dendritic cells (DC) used for clinical trials should be processed on a large scale conforming to current good manufacturing practice (cGMP) guidelines. The aim of this study was to develop a protocol for clinical grade generation of immature DC in a closed-system. Aphereses were performed with the Cobe SpectraÔ continuous flow cell separator and material was derived from one volume of blood processed. Optimisation of a 3-phase collection autoPBSC technique significantly improved the quality of the initial mononuclear cell (MNC) product. Monocytes were then enriched from MNC by immunomagnetic depletion of CD19+ B cells and CD2+ T cells and partial depletion of NK cells using the Isolex 300I Magnetic cell selector. The quality of the initial mononuclear cell product was found to determine the outcome of monocyte enrichment. Enriched monocytes were cultured in Opticyte gas-permeable containers using CellGro serum-free medium supplemented with GM-CSF and IL-4 to generate immature DC. A seeding concentration of 1 × 106 was found optimal in terms of DC phenotype expression, monocyte percentage in culture, and cell viability. The differentiation pattern favours day 7 for harvest of immature DC. DC recovery, viability, as well as phenotype expression after cryopreservation of immature DC was considered in this study. DC were induced to maturation and evaluated in FACS analysis for phenotype expression and proliferation assays. Mature DC were able to generate an allogeneic T-cell response as well as an anti-CMV response as detected by proliferation assays. These data indicate that the described large-scale GMP-compatible system results in the generation of stable DC derived from one volume of blood processed, which are qualitatively and quantitatively sufficient for clinical application in immunotherapeutic protocols. J. Clin. Apheresis © 2005 Wiley-Liss, Inc. [source] Safety and quality of plastic food contact materials.PACKAGING TECHNOLOGY AND SCIENCE, Issue 5 2003Optimization of extraction time, based on arithmetic rules derived from mathematical description of diffusion., extraction yield Abstract Migration of packaging constituents into food may raise concerns about food safety. This paper describes the conclusions of a EU research project (AIR 941025), aiming to facilitate the introduction of migration control into good manufacturing practice and into enforcement policies. The first part describes a re-evaluation of analytical approaches to extract and identify potential migrants released by plastic materials, viz. comparison of analytical methods, choice of extraction solvents and of fat simulants. Here we focus on the extraction time needed to achieve a given extraction yield. By correlating these parameters with simple and practical equations, it is possible to design alternative tests for control of compliance of packaging plastics. Using a reference experiment (where there is good agreement between experimental and calculated kinetic curves), it is possible to calculate the percentage of extraction which can be achieved in a given time, or the time necessary to reach a target extraction level for other polymer/solvent combinations. A global control scheme is proposed, which indicates whether and when calculation and testing should be applied. Guidelines are proposed, and can be adapted to both industrial control and to enforcement laboratories. Copyright © 2003 John Wiley & Sons, Ltd. [source] LEAN, GREEN, AND THE QUEST FOR SUPERIOR ENVIRONMENTAL PERFORMANCEPRODUCTION AND OPERATIONS MANAGEMENT, Issue 3 2001SANDRA ROTHENBERG We examine the relationship between lean manufacturing practices and environmental performance as measured in terms of air emissions and resource use. We draw on two unique surveys of 31 automobile assembly plants in North America and Japan, which contain information on manufacturing practice and environmental performance, as well as in-depth interviews with 156 plant level employees at 17 assembly plants. Our survey results and interviews suggest that lean management and reduction of air emissions of volatile organic compounds (vocs) are associated negatively. Lean manufacturing practices contribute to more efficient use of paints and cleaning solvents, but these in-process changes are not sufficient to meet the most stringent air regulations. We found some evidence to support the link between lean practices and resource efficiency. While our survey results were in hypothesized direction, they were not statistically significant. In-depth semi-structured interviews, however, suggest a more robust relationship, and we use them to describe some mechanisms by which all three aspects of lean management (buffer minimization, work systems, and human resource management) may be related to environmental management practices and performance. [source] Design Vulnerability Analysis and Design Improvement by Using Warranty DataQUALITY AND RELIABILITY ENGINEERING INTERNATIONAL, Issue 2 2004Kai Yang Abstract Continuous improvement in reliability is one of the key factors to success in the world automobile market. Good reliability can only be achieved through good design and manufacturing practice. Manufacturers want to allocate their limited resources to improvement in such a way that they can get the highest benefits. The warranty claims database contains more information than any other test for the reliability of products in actual use. Assisted by a design vulnerability index derived from the axiomatic design principle, warranty data can be used to identify the areas of the product such that the improvement of these areas will maximize the gain in reliability improvement. In this paper, we provide a methodology of utilizing warranty data to prioritize design improvement efforts based on design vulnerability and the feedback from warranty data. The methodology is illustrated with an example case. Copyright © 2004 John Wiley & Sons, Ltd. [source] Does Canada Need Mandatory HACCP?CANADIAN JOURNAL OF AGRICULTURAL ECONOMICS, Issue 4 2006Evidence from the Ontario Food Processing Sector The likelihood of the voluntary adoption of hazard analysis and critical control point (HACCP) among food processing firms is evaluated by exploring the perceptions of food safety managers with respect to a range of possible motivating factors including the exogenous pressure to adopt HACCP, efficacy of existing food safety controls, perception that HACCP will improve the firm's food safety controls, relative costs and benefits of HACCP implementation, impact of HACCP on business performance, and the nature of barriers to implementing HACCP. While market-based factors exert substantial pressure on firms to adopt HACCP, many food safety managers perceive that their existing food safety controls are adequate to meet existing food safety demands. While good manufacturing practice (GMP) and traceability are considered the most efficacious food safety controls, HACCP is most often perceived to provide intangible and "incidental" benefits that are often not recognized by food safety managers a priori. An important barrier to the voluntary adoption of HACCP is the perceived questionable appropriateness of HACCP for enhancing food safety controls, while financial constraints can be an absolute barrier to implementation. The results suggest a number of potential strategies through which the implementation of HACCP might be facilitated and enhanced through cooperation and coordination between regulators and industry organizations. La probabilité que les entreprises de transformation des aliments adoptent volontairement le système HACCP (analyse des risques et maîtrise des points critiques) a étéévaluée en examinant les perceptions des gestionnaires de sécurité alimentaire envers certains facteurs de motivation possibles tels que la pression exogène, l'efficacité des moyens de contrôle existants, la perception voulant que le système HACCP améliore le contrôle de la sécurité alimentaire de l'entreprise, les coûts et les avantages relatifs de la mise en place du système, les répercussions du système sur la performance de l'entreprise et la nature des obstacles à la mise en place du système. Bien que des facteurs de marché exercent d'importantes pressions pour que les entreprises adoptent ce système, de nombreux gestionnaires de sécurité alimentaire estiment que leurs moyens de contrôle existants répondent adéquatement aux demandes actuelles de sécurité alimentaire. Bien que les bonnes pratiques de fabrication (BPF) et la traçabilité soient considérées comme les moyens de contrôle de la sécurité alimentaire les plus efficaces, le système HACCP est le plus souvent perçu comme procurant des avantages intangibles et ,accessoires, qui, souvent, ne sont pas reconnus a priori par les gestionnaires de sécurité alimentaire. La pertinence discutable perçue du système HACCP comme moyen d'améliorer le contrôle de la sécurité alimentaire constitue un important obstacle à l'adoption volontaire du système, bien que les contraintes financières peuvent être un obstacle absolu à sa mise en place. Les résultats suggèrent un certain nombre de stratégies potentielles grâce auxquelles la mise en place du système pourrait être facilitée et améliorée par la collaboration et la coordination entre les organismes de réglementation et les entreprises de l'industrie de la transformation des aliments. [source] Overcoming barriers to implementing environmentally benign manufacturing practices: Strategic tools for SMEsENVIRONMENTAL QUALITY MANAGEMENT, Issue 3 2009Manuel Seidel First page of article [source] An international survey of the use and effectiveness of modern manufacturing practicesHUMAN FACTORS AND ERGONOMICS IN MANUFACTURING & SERVICE INDUSTRIES, Issue 2 2002C. W. Clegg We describe a survey of the use and effectiveness of 12 manufacturing practices. The survey was administered to a random, stratified sample of companies with 150 or more employees in the United Kingdom, Australia, Japan, and Switzerland, yielding a total sample of 898 companies. We report findings on the extent of use of the practices, when they were introduced, their predicted future use, their effectiveness, and the correlates of their use and effectiveness. The data are examined for differences by country of location and country of ownership, as well as by industrial sector. © 2002 Wiley Periodicals, Inc. [source] SURVEY OF APPLE GROWING, HARVESTING, AND CIDER MANUFACTURING PRACTICES IN WISCONSIN: IMPLICATIONS FOR SAFETYJOURNAL OF FOOD SAFETY, Issue 2 2000HEIDI E. ULJAS ABSTRACT To evaluate the safety of current apple growing, harvesting and cider manufacturing practices in Wisconsin, cider manufacturers were contacted in a three-phase survey. Results revealed that seasonal, small-scale production was characteristic of the industry. Most cider mills produced less than 5,000 gal/year; only 6% produced more than 20,000 gal/year. Most cider makers used only tree picked apples (86%), inspected apples before washing (94%), washed (93%) and brushed (87%) apples, but only 16% of mills sanitized washed apples. Most mills (92%) sanitized cider making equipment after each use; however, only a few sanitized between custom pressing apples from different customers. Respondents reported that they strived to improve cider safety by pasteurization (43% of all cider), UV light treatment (4%), use of preservatives (30%), and HACCP (17%). For 31% of all cider, however, processors relied solely on refrigeration and/or freezing. These results show that most cider mills practice many steps believed to enhance cider safety, but results also identify procedures that must be addressed to further improve cider safety. [source] Food Defense in an Aquaculture SettingJOURNAL OF THE WORLD AQUACULTURE SOCIETY, Issue 2 2010Barbara Rasco Developing an overall food protection program for aquaculture and its related food processing operations includes biosecurity and good aquaculture practices for husbandry operations, and good manufacturing practices, food safety (sanitation standard operating procedures, and hazard analysis critical control point) programs for processing. Because of recent intentional contamination incidents of food and feed, developing and implementing a food defense as part of an overall food safety and quality management system have become more critical. Recent developments in food defense, suitable preventive measures, mitigation strategies, and model implementation plans for an aquaculture operation are presented here. [source] LEAN, GREEN, AND THE QUEST FOR SUPERIOR ENVIRONMENTAL PERFORMANCEPRODUCTION AND OPERATIONS MANAGEMENT, Issue 3 2001SANDRA ROTHENBERG We examine the relationship between lean manufacturing practices and environmental performance as measured in terms of air emissions and resource use. We draw on two unique surveys of 31 automobile assembly plants in North America and Japan, which contain information on manufacturing practice and environmental performance, as well as in-depth interviews with 156 plant level employees at 17 assembly plants. Our survey results and interviews suggest that lean management and reduction of air emissions of volatile organic compounds (vocs) are associated negatively. Lean manufacturing practices contribute to more efficient use of paints and cleaning solvents, but these in-process changes are not sufficient to meet the most stringent air regulations. We found some evidence to support the link between lean practices and resource efficiency. While our survey results were in hypothesized direction, they were not statistically significant. In-depth semi-structured interviews, however, suggest a more robust relationship, and we use them to describe some mechanisms by which all three aspects of lean management (buffer minimization, work systems, and human resource management) may be related to environmental management practices and performance. [source] Musculoskeletal tissue banking in Western Australia: review of the first ten yearsANZ JOURNAL OF SURGERY, Issue 8 2005Joyleen M. Winter Background: Musculoskeletal tissue allotransplantation has been used as a standard approach for reconstructive surgery. The present study has reviewed the banking of musculoskeletal tissue at the Perth Bone and Tissue Bank (PBTB) and provided evidence of quality assurance on musculoskeletal tissue allotransplantation. Methods: All donor tissues were processed in accordance with the Therapeutic Goods Administration's relevant codes of good manufacturing practices. Microbiological monitoring at each step of manufacture and postoperative surveying of the musculoskeletal allotransplantations were both conducted. The possible contribution of contaminants in allografts to postoperative infections was also assessed. Results: Of the 5276 donors obtained over the last 10 years, 1672 were rejected, giving an overall donor rejection rate of 32%. Milled femoral heads were the most frequently implanted allografts, followed by whole femoral heads. In the postoperative survey an infection rate of 4.9% was found (113/2321 recipients). The infectious agents were identified in 65 cases but for 60 of these there were no correlations with the positive culture test results for the allografts. The organism most commonly identified in postoperative infections was Staphylococcus species. Conclusions: The present study shows evidence that musculoskeletal tissue allotransplantation is a safe procedure when accompanied by high standards of quality assurance. [source] | |||||||||||||||||||