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Latest Edition EJPPS Volume 22 Issue 1; Microbial contamination risks on surface ; Contact plates

05 April 2017   (0 Comments)
Posted by: Tamsin Marshall
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Latest Issue

Volume 22 Issue 1

 

Contents

Editorial: Annex 1 and memory loss

Peer-reviewed Papers

Microbial contamination risks of the surface of surgical clothing systems – an observational study
Catinka Ullmann, Bengt Ljungqvist and Berit Reinmüller

Abstract: The personnel in an operating room are usually the main source of microorganisms and the correct clothing system for staff is, therefore, of high importance for patient safety. The same surgical clothing system is often worn during a complete working day/shift, i.e. no change of clothing between operations, and the personnel may also leave the surgical department/section for different reasons.  The aim of this study was to investigate the risk of contaminating the outside of the surgical clothing during a day of use and also to evaluate if there is a higher risk of contamination if staff visit areas outside the surgical department.

 

Use of contact plates to perform environmental settle plate testing
Aleshia Samson, Andrew Sage and David Jones - Rapid Micro Biosystems, USA
Abstract: An evaluation was performed to investigate the use of contact plates in place of Petri plates to perform environmental monitoring settle plates. A Petri plate has approximately 2.5 times the surface area of a contact plate and a different agar profile for exposure to air. Petri plates also have plastic walls that extend above the agar surface and may affect air flows. To evaluate the possible use of contact plates, analysis of capture and recovery of bioburden was performed in a number of different environments, with differing numbers of exposed plates. Overall, a good correlation was shown when two contact plates were used as a substitute for one Petri plate with a 4-hour exposure time. The ability to use contact plates for a settle plate test allows the use of a single consumable, the contact plate, to be stocked for environmental monitoring testing.

Science and Technology Papers
Review on endotoxin-mediated toxic anterior segment syndrome (TASS) in ophthalmic products – outbreaks, product recall and testing limits
R. Vijayakumar, Mohammad Saleh Al- Aboody, Wael Alturaiki and Tim Sandle
Abstract: Ophthalmic products are at risk from direct or indirect contamination from Gram-negative bacteria. A by-product of Gram-negative bacteria is the lipopolysaccharide component of the cell wall (commonly known as endotoxin). Bacterial endotoxin is a potent ocular inflammatory agent and causes ‘toxic anterior segment syndrome’. This paper reviews the patient risks from endotoxin and considers the sources of endotoxin in relation to the production of ophthalmic surgical products. The paper also considers the main product contamination recalls during the past decade. The risks and requirements for testing are then considered in light of current regulatory guidances. We conclude by making recommendations for endotoxin and bioburden control for manufacturing and in setting out appropriate endotoxin test limits for the testing of finished ophthalmic products.


Regulatory review 
Malcolm Holmes
PHSS activity and initiatives report


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