〈1208〉 Sterility Testing—Validation of Isolator Systems

2021 ◽  
Keyword(s):  
Sterility Testing

The Sterility of Reusable Surgical Instruments with Pouches Packaging on One of the Private Hospital in Bandung

2017 ◽  
Vol 8 (2) ◽  
Author(s):  
Kurniawansyah I. S. ◽  
Mita S. R. ◽  
Najla E. ◽  
Nindayani E.
Keyword(s):  
Storage Time ◽  
Private Hospital ◽  
Surgical Instruments ◽  
Healthcare Associated Infection ◽  
Sterility Testing ◽  
Reusable Instruments ◽  
Healthcare Associated ◽  
The Relationship ◽  
Common Infection ◽  
Long Storage

Healthcare associated infection is one of the common infection that happens in Indonesia. One form control to prevent healthcare associated infection is the sterilization process of the materials and medical instruments that used for taking care of patients. At the private hospital whereas a place of research, there’s never been done the study of sterility test for reusable instrument with pouches, based on previous studies showed that 8 sets from 40 sets of reusable instrument with linen were not sterile moreover there were positively influence from the amount of time to the sterility of reusable instrument. The purpose of these studies was to determining the relationship between a long storage time and the sterility of reusable instruments with pouches. The method that used in this study was the sterility testing of reusable instrument with pouches which were stored in a central operations room storage with a long storage time of 1 and 2 months. From 30 reusable instruments with pouches which were stored for nine months there were 5 instruments were not sterile. The results of statistic analysis showed that the amount of storage time not significantly associated to the sterility of reusable instrument with pouches in the operating room central storage space.

scholarly journals Nutrição parenteral: panorama das amostras analisadas no Instituto Nacional de Controle de Qualidade em Saúde

2020 ◽  
Vol 10 (3) ◽  
Author(s):  
Mariana Bruno Rodrigues Benitez ◽  
Verônica Viana Vieira ◽  
Célia Maria Carvalho Pereira Araujo Romão
Keyword(s):  
Parenteral Nutrition ◽  
Cross Section ◽  
Scientific Literature ◽  
Clinical Importance ◽  
Safe Medication ◽  
Good Practices ◽  
Sterility Testing ◽  
Treatment And Prevention ◽  
Qualitative Descriptive

Background and objectives: Total parenteral nutrition (TPN) has great clinical importance in malnutrition treatment and prevention in patients with digestive problems. Although good practices for handling TPN are well established, contamination of these products still occurs, and this product remains listed as a higher risk drug by the Institute for Safe Medication Practices. The present study aimed to obtain an overview of the documentary data of the parenteral nutrition samples sent to the National Institute for Quality Control in Health (INCQS) of Fundação Oswaldo Cruz. Methods: This is a qualitative descriptive and quantitative study carried out based on a cross-section of TPN samples analyzed from 2000 to 2016. Results: A total of TPN 134 samples were sent during the study period. 11.20% of the samples were sent in 2001, 0.80% in 2005, 8.20% in 2006, 16.40% in 2007, 63.40% in 2013. Six samples (4.5%) were canceled and 113 submitted to sterility testing, resulting in 13.3% unsatisfactory samples. Conclusion: During the study period, four suspected events of enterobacterial contamination in TPNs administered to patients were reported, three of which have not yet been described in the scientific literature. For the safety of patients using TPN to be guaranteed, it is suggested that the norms that regulate TPN therapy be reviewed and updated, and programs to monitor the quality of these preparations should be established.

scholarly journals Emulsion of Chloramphenicol: an Overwhelming Approach for Ocular Delivery

Folia Medica ◽  
2017 ◽  
Vol 59 (1) ◽  
pp. 23-30 ◽  
Author(s):  
Kalpesh C. Ashara ◽  
Ketan V. Shah
Keyword(s):  
Ternary Phase Diagram ◽  
Ex Vivo ◽  
Sterility Testing ◽  
Ocular Irritation ◽  
Peg 400 ◽  
Significant Difference ◽  
Oil Mixtures ◽  
Student’S T ◽  
The Impact

Abstract Background: Ophthalmic formulations of chloramphenicol have poor bioavailability of chloramphenicol in the ocular cavity. Aim: The present study aimed at exploring the impact of different oil mixtures in the form of emulsion on the permeability of chloramphenicol after ocular application. Materials and methods: Selection of oil mixture and ratio of the components was made by an equilibrium solubility method. An emulsifier was chosen according to its emulsification properties. A constrained simplex centroid design was used for the assessment of the emulsion development. Emulsions were evaluated for physicochemical properties; zone of inhibition, in-vitro diffusion and ex-vivo local accumulation of chloramphenicol. Validation of the design using check-point batch and reduced polynomial equations were also developed. Optimization of the emulsion was developed by software Design® expert 6.0.8. Assessment of the osmolarity, ocular irritation, sterility testing and isotonicity of optimized batch were also made. Results: Parker Neem®, olive and peppermint oils were selected as an oil phase in the ratio 63.64:20.2:16.16. PEG-400 was selected as an emulsifier according to a pseudo-ternary phase diagram. Constrained simplex-centroid design was applied in the range of 25-39% water, 55-69% PEG-400, 5-19% optimized oil mixture, and 1% chloramphenicol. Unpaired Student’s t-test showed for in-vitro and ex-vivo studies that there was a significant difference between the optimized batch of emulsion and Chloramphenicol eye caps (a commercial product) according to both were equally safe. Conclusion: The optimized batch of an emulsion of chloramphenicol was found to be as safe as and more effective than Chloramphenicol eye caps.

Comprehensive Study Identifies a Sensitive, Low-Risk, Closed-System Model for Detection of Fungal Contaminants in Cell and Gene Therapy Products

2021 ◽  
Author(s):  
Nicole E. Putnam ◽  
Anna F. Lau
Keyword(s):  
Closed System ◽  
Test Performance ◽  
The United States ◽  
Diverse Range ◽  
Sterility Testing ◽  
Delayed Entry ◽  
Test Sensitivity ◽  
Food And Beverage ◽  
Testing Algorithm ◽  
Fungal Contaminants

The United States Food and Drug Administration (FDA) regulates manufacturing and testing of advanced therapeutic medicinal products (ATMPs) to ensure the safety of each product for human use. Gold standard sterility testing (USP<71>) and alternative blood culture systems have major limitations for the detection of fungal contaminants. In this study, we evaluated the performance of i LYM media (designed originally for the food and beverage industry) to assess its potential for use in the biopharmaceutical field for ATMP sterility testing. We conducted a parallel evaluation of four different test systems (USP<71>, BacT/ALERT, BACTEC, and Sabouraud Dextrose Agar [SDA] culture), three different bottle media formulations ( i LYM, i FA + , and Myco/F Lytic), and two incubation temperatures (22.5°C and 32.5-35°C) using a diverse set of fungi ( n =51) isolated from NIH cleanroom environments and previous product contaminants. Additionally, we evaluated the effect of agitation versus “delayed entry” static pre-incubation on test sensitivity and time to detection (TTD). Overall, delayed entry of bottles onto the BacT/ALERT or BACTEC instruments (with agitation) did not improve test performance. USP<71> and SDA culture continued to significantly outperform each automated culture condition alone. However, we show for the first time, that a closed-system, dual-bottle combination of i LYM 22.5°C and i FA + 32.5°C can provide high fungal sensitivity, statistically comparable to USP<71>, when tested against a diverse range of environmental fungi. Our study fills a much-needed gap in biopharmaceutical testing and offers a favorable testing algorithm that maximizes bacterial and fungal test sensitivity whilst minimizing risk of product contamination associated with laboratory handling.

Alcohol Flaming—A Possible Source of Contamination in Sterility Testing

1969 ◽  
Vol 51 (3_ts) ◽  
pp. 407-408 ◽  
Author(s):  
John E. Doyle ◽  
Robert R. Ernst
Keyword(s):  
Sterility Testing
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