scholarly journals Decontamination and Validation of Isolators for Sterility Testing

2016 ◽  
Vol 50 (s3) ◽  
pp. 27-33
Author(s):  
Maria Luisa Bernuzzi

Abstract Decontamination with hydrogen peroxide is a technology widely used to reduce microbial contamination. A typical application of this technology is in the decontamination of sterility test isolators. This article describes how to decontaminate sterility test isolators and validate the process in order to demonstrate that the microbiological target has been achieved and that the risk of false negatives due to residuals of hydrogen peroxide is excluded. Hydrogen peroxide can adversely affect some materials, resulting in inhibition of microbial growth. A package integrity verification, focused on the risk of penetration of decontaminating agent into different product containers and through different materials, is one of the main topics. Several case studies let readers understand the most critical items, choose their materials correctly, and validate the process itself. Hydrogen peroxide measurements on the surface of several materials, inside the primary packaging container, and inside aqueous solutions are part of this article. Validation of the decontamination cycle as well as validation of the operative procedure are key elements for a good laboratory practices approach.

Author(s):  
Shanmugam S ◽  
Valarmathi S ◽  
Satheesh Kumars

  Objective: The present work focuses on sterility studies of prepared aciclovir ocusert which is so essential for ophthalmic preparations. According to Indian Pharmacopoeia, the sterility test was performed. Ocuserts are sterile preparations which are placed into cul-de-sac or conjunctival sac. Ophthalmic inserts offer many advantages over conventional dosage forms such as increased ocular residence time, possibility of releasing drugs at a slow and constant rate and accurate dosing. Ocuserts are formulated for treating external ocular diseases such as conjuctivitis, corneal ulcer, and keratoconjuctivitis. Ophthalmic preparations contaminated with microorganisms cause corneal damage and finally blindness, especially if the microorganism is Pseudomonas aeruginosa. Ophthalmic preparations should be manufactured in aseptic condition and to be sterilized before packing.Methods: According to Indian Pharmacopoeia, the official sterility test for ocusert was performed for detecting the presence of microbes. The selected F2 formulation which shows controlled drug release after 24 hrs was selected for the sterility test. The F2 formulation was subjected to ultraviolet radiation for sterilization. The sterilized ocusert and unsterilized ocusert were placed in fluid thioglycollate medium and incubated for 7 days at 20-25oC.Results: After 7 days of incubation, the sterilized ocusert shows no microbial growth and unsterilized ocusert shows microbial growth. The prepared aciclovir ocuserts were found to be sterile after the completion of official sterility test.Conclusion: The sterility studies conclude after 7 days of incubation period; there was no appearance of turbidity which indicates the prepared formulation F2 was found to be sterile.


2018 ◽  
Vol 84 (17) ◽  
Author(s):  
Claire Zoellner ◽  
Mohammad Abdullah Al-Mamun ◽  
Yrjo Grohn ◽  
Peter Jackson ◽  
Randy Worobo

ABSTRACTFresh produce supply chains present variable and diverse conditions that are relevant to food quality and safety because they may favor microbial growth and survival following contamination. This study presents the development of a simulation and visualization framework to model microbial dynamics on fresh produce moving through postharvest supply chain processes. The postharvest supply chain with microbial travelers (PSCMT) tool provides a modular process modeling approach and graphical user interface to visualize microbial populations and evaluate practices specific to any fresh produce supply chain. The resulting modeling tool was validated with empirical data from an observed tomato supply chain from Mexico to the United States, including the packinghouse, distribution center, and supermarket locations, as an illustrative case study. Due to data limitations, a model-fitting exercise was conducted to demonstrate the calibration of model parameter ranges for microbial indicator populations, i.e., mesophilic aerobic microorganisms (quantified by aerobic plate count and here termed APC) and total coliforms (TC). Exploration and analysis of the parameter space refined appropriate parameter ranges and revealed influential parameters for supermarket indicator microorganism levels on tomatoes. Partial rank correlation coefficient analysis determined that APC levels in supermarkets were most influenced by removal due to spray water washing and microbial growth on the tomato surface at postharvest locations, while TC levels were most influenced by growth on the tomato surface at postharvest locations. Overall, this detailed mechanistic dynamic model of microbial behavior is a unique modeling tool that complements empirical data and visualizes how postharvest supply chain practices influence the fate of microbial contamination on fresh produce.IMPORTANCEPreventing the contamination of fresh produce with foodborne pathogens present in the environment during production and postharvest handling is an important food safety goal. Since studying foodborne pathogens in the environment is a complex and costly endeavor, computer simulation models can help to understand and visualize microorganism behavior resulting from supply chain activities. The postharvest supply chain with microbial travelers (PSCMT) model, presented here, provides a unique tool for postharvest supply chain simulations to evaluate microbial contamination. The tool was validated through modeling an observed tomato supply chain. Visualization of dynamic contamination levels from harvest to the supermarket and analysis of the model parameters highlighted critical points where intervention may prevent microbial levels sufficient to cause foodborne illness. The PSCMT model framework and simulation results support ongoing postharvest research and interventions to improve understanding and control of fresh produce contamination.


2014 ◽  
Vol 966-967 ◽  
pp. 357-364 ◽  
Author(s):  
Marvin Redetzky ◽  
Andreas Rabenstein ◽  
B. Palmowski ◽  
Ekkard Brinksmeier

Most of the several billion liters of metalworking fluid (MWF) used worldwide and annually are water-based and thus prone to a microbial contamination. The microbial growth leads to a deterioration and therefore to a loss of quality and technical performance. In most cases, biocides, which pose a potential risk to health and environment, are used to reduce the microbial load. To avoid these limitations, the paradigm shift of using microorganisms in a positive way in a manufacturing process as a lubricant is investigated in this paper. Some microorganisms are able to synthesize equivalent MWF components like e.g. fatty acids or sulfur compounds. Due to this fact, it is possible to create a regenerative system on a microbiological basis for the substitution of mineral oil containing MWF components. To demonstrate the lubrication potential of bacteria, preliminary investigations were conducted on a Brugger-tribotester. Against this background, the approach presented here intends to investigate the lubrication properties of special microorganisms and the influence of the microbial cell counts on the lubrication behavior respectively. The results of the tribological tests show that the microbial-suspensions exhibit Brugger-values as high as highly concentrated conventional MWF and indicate the potential to replace these respective components.


2007 ◽  
Vol 342-343 ◽  
pp. 905-908 ◽  
Author(s):  
Mi Hee Lee ◽  
Yeon I Woo ◽  
In Seop Lee ◽  
Jeong Koo Kim ◽  
Jong Chul Park

Tissue-engineering must be either manufactured aseptically or sterilized after processing. To extend protection of medical devices against microbial contamination, various sterilization methods have been suggested. Hydrogen peroxide gas plasma sterilization has been applied in hospitals worldwide for almost a decade. In this study, we investigated the sterilization efficacy of hydrogen peroxide gas plasma sterilizer with porous polyurethane sample. The result is suggested that hydrogen peroxide gas plasma can be applicable to the sterilization of polymer scaffold for tissue engineering materials.


2020 ◽  
Vol 5 (1) ◽  
pp. 7-11
Author(s):  
Erlien Dwi Cahyani ◽  
Agus Purwanto

The wider community, especially mothers and adolescents, have not been aware of the importance of using hygienic cosmetic products. Microbial contamination in cosmetics can occur due to the use of unhygienic applicators and the exchange of cosmetics between users. In addition, improper cosmetics storage in warm and humid places triggers microbial growth. Based on this, it is necessary to educate cosmetic microbial contamination of PKK RW 09 Bumi Antariksa Residence Madiun. The activities carried out through lectures, interactive discussions, consultations and assistance related to the use of cosmetics material and storage are good to minimize microbial contamination. Educational activities have succeeded in increasing partner knowledge about the correct handling of cosmetics including the use, the expiration of cosmetics and its storage and increasing knowledge concerning the prevention of microbial contamination in cosmetics including the correct handling of applicators and the use of cosmetics together. Keywords—: education; microbial contamination; cosmetics; bumi antariksa.


2020 ◽  
Vol 8 (2) ◽  
pp. 244-254
Author(s):  
Zahira Murhaf AL-Khani ◽  
Hadeel T. AL-Hadithi

Introduction: Contact lenses (CLs) are medical or cosmetic devices, comfortable and more convenient alternative to eyeglasses. Eye infection will result when microbes are introduced onto CLs, because defense against microbial invasion in the anterior chamber of the eyes is weak due to the very poor blood supply. Method: The present study investigates hygienic habits, attitudes and practices of thirty CL wearers, toward lens care, that might yield to microbial contamination of CL units through examination of 120 samples (4 items of each CL units) to detect microbial growth and to understand associated factors through a structured questionnaire. Results: Microbial contamination was detected in at least one item of twenty-five CL units (83.3%). None of disinfecting care solutions in original bottles was found contaminated. Incidence of microbial contamination in storage case (Right and Left) and rims of solution bottles was 21 (70%), 17 (56.7%) and 6 (20%) respectively. Eye redness after CLs wearing was almost a statistically significant sign associated with contaminated CL units (p=0.088). Using water only to wash hands and CL storage cases has been incriminated for increased contamination. Conclusions: Impurities in CL storage cases have led to reduced efficacy of disinfectant care solutions. Value-added awareness of CL wearers should be improved by regular visit to eye care professionals.


1983 ◽  
Vol 46 (12) ◽  
pp. 1060-1064 ◽  
Author(s):  
CATHERINE J. STANNARD ◽  
JOHN S. ABBISS ◽  
JOHN M. WOOD

A treatment combining hydrogen peroxide and ultra-violet (UV-C) irradiation was assessed for reduction of microbial contamination in pre-formed food packaging cartons. There was a synergistic effect between low concentrations (0 – 5% wt/vol) of hydrogen peroxide and UV-C irradiation (10 s) on spores of Bacillus subtilis, the maximum lethality occurring between 0.5 and 1% peroxide. A combined treatment using 1% hydrogen peroxide and 10 s of UV-C irradiation was also effective against a variety of other organisms (spores and vegetative cells). The efficiency of the treatment was dependent on the type of inner surface of the carton. A greater lethal effect was obtained against B. subtilis spores in polyethylene-lined cartons than in aluminium/polyethylene laminate-lined cartons (5.1 and 3.5 decimal reductions in numbers respectively, using a combined treatment with 1% peroxide and 10 s of UV-C).


2017 ◽  
Vol 13 (1) ◽  
pp. 27-35 ◽  
Author(s):  
Adriana Bugno ◽  
Deborah Pita Sanches Saes ◽  
Adriana Aparecida Buzzo Almodovar ◽  
Kamal Dua ◽  
Rajendra Awasthi ◽  
...  

2008 ◽  
Vol 71 (3) ◽  
pp. 639-642 ◽  
Author(s):  
ILENYS M. PÉREZ-DÍAZ ◽  
VAN-DEN TRUONG ◽  
ASHLEE WEBBER ◽  
ROGER F. MCFEETERS

Refrigerated sweet potato puree is a convenient form of sweet potato that can be used as an ingredient in formulated foods. The microbiology of refrigerated sweet potato puree during storage for up to 5 weeks was evaluated. Because the puree was made by comminuting steam-cooked sweet potatoes before refrigeration, no naturally occurring vegetative bacterial cells were detected during a 4-week period of refrigerated storage at 4°C. However, if postprocessing microbial contamination of the puree were to occur, contaminating microorganisms such as Listeria monocytogenes could grow during refrigerated storage. The effects of acidification or the addition of potassium sorbate and sodium benzoate on a population of L. monocytogenes inoculated into refrigerated (4°C) sweet potato puree were determined. Inoculation of the refrigerated puree with L. monocytogenes at 106 CFU/ml resulted in a 3-log increase after 3 weeks storage of nonsupplemented puree. Supplementation of the sweet potato puree with 0.06% (wt/vol) sorbic acid or benzoic acid plus mild acidification of the sweet potato puree with citric acid to pH 4.2 prevented growth of L. monocytogenes during storage at 4°C.


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