Prüfung eines Testsystems zur mikrobiologischen Barrierewirksamkeit von Sterilgutverpackungen (Papier- Folien- Verbundverpackungen) nach Transport und Lagerung

Examination of a test system for microbial barrier effectiveness of packing units for sterile products (paper-foil laminate packing) after transport and storage

by Katharina Niemeyer
Doctoral thesis
Date of Examination:2014-06-30
Date of issue:2014-06-18
Advisor:Prof. Dr. Hartmut Dunkelberg
Referee:Prof. Dr. Utz Reichard
Referee:Prof. Dr. Rainer Mausberg
Persistent Address: http://dx.doi.org/10.53846/goediss-4547

 

 

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Abstract

English

Objectives: The aim of our study was to develop a method or a tool for verifying the effectiveness of the microbial barrier of packing units for sterile products towards airborne microorganisms during storage and transport and to test their applicability under realistic conditions of everyday practice. The test method should be carried out using the paper-film laminate packing and serving the user to verify the effectiveness of the sterile barrier system towards the occurred microbiological stress until application of sterile products. Methods: The investigation is based on a co-sterilized nutrient board in the sterile packing and an activation part, that enables the cultivation of penetrated microorganisms through the paper-side and can prove recontamination of the initially sterile product this way without opening the packing system for this proof. The storage of the test units was performed at different locations with different environmental conditions (bacterial count of the ambient air measured as CFU/m³ = colony-forming units/cubic metre / pressure differences / temperature changes) to create a graduation of exposure scenarios. Storage locations: Hospital for heart and vascular diseases (150 CFU/m³ / atmospheric pressure differences / air-conditioned premises); warehouse for sterile products (350 CFU/m³ / atmospheric pressure differences / temperature equal to the outside temperature); 3 different buildings for grain storage (8,3*106 CFU/m³ / atmospheric and by elevator rides pressure differences / temperature equal to the outside temperature). Results: With the calculated microbiological stress for the test units deposited in the hospital and in the warehouse for sterile products (0,051 CFU and 0,608 CFU) none of these test units showed a recontamination. However, for the investigations in the buildings for grain storage with the calculated microbiological stress for the packing system (>8400 CFU) a recontamination of the test units about 84,2% was shown. Conclusions: As shown by this study under realistic conditions, it has been possible to develop a test for sterile packaging systems, that allows an assessment of the current microbiological status of the packaged good immediately before its application.
Keywords: sterile barrier system
 
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