Performance Survey and Comparison Between Rapid Sterility Testing Method and Pharmacopoeia Sterility Test

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.

Download Full-text

STERILITY TESTING PROCEDURE OF OPHTHALMIC OCUSERT ACICLOVIR USED FOR TREATING HERPES SIMPLEX VIRUS

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2017.v10i10.19216 ◽

2017 ◽

Vol 10 (10) ◽

pp. 344 ◽

Cited By ~ 1

Author(s):

Shanmugam S ◽

Valarmathi S ◽

Satheesh Kumars

Keyword(s):

Microbial Growth ◽

Corneal Ulcer ◽

Controlled Drug Release ◽

Testing Procedure ◽

Ocular Diseases ◽

Sterility Testing ◽

Sterility Test ◽

Constant Rate ◽

Corneal Damage ◽

Simplex Virus

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.

Download Full-text

Removal of bacterial growth inhibition of anticancer drugs by using complexation materials

Pharmaceutical Technology in Hospital Pharmacy ◽

10.1515/pthp-2019-0018 ◽

2020 ◽

Vol 5 (1) ◽

Author(s):

Maïté Sangnier ◽

Guillaume Bouguéon ◽

Aude Berroneau ◽

Véronique Dubois ◽

Sylvie Crauste-Manciet

Keyword(s):

Activated Carbon ◽

Anticancer Drugs ◽

Bacterial Growth ◽

Inhibitory Effect ◽

Cytotoxic Drugs ◽

Microbiological Method ◽

Batch Production ◽

Sterility Testing ◽

Sterility Test ◽

Aspergillus Brasiliensis

AbstractIn the context of batch production of cytotoxic drugs in hospital pharmacies with the need of sterility testing, the objective was to validate the use of Rapid Microbiological Method (RMM), and to develop adequate neutralization method in case of inhibition of bacterial growth. The potential microbiological growth inhibitory effect of three anticancer drugs (5 fluorouracil, irinotecan and oxaliplatin) selected for batch production was assessed on BacT/ALERT® system. Among cytotoxic drugs, only 5FU exhibited inhibitory effect on microbiological growth using rapid microbiological method. To counteract this effect our purpose was to use neutralizing agents complexing the drug i. e. activated carbon or ion exchange resins. The microbiological bactericidal concentration of 5FU was very low (1.10–4 mg/mL) indicating the absolute need to neutralize the whole drug before sterility test. The complexation was validated by High Performance Liquid Chromatography control of the residual 5FU concentration in solution after the use of neutralizing agents. Only activated carbon was able to fully capture 5FU when previously diluted at 5 mg/mL. Conversely, the resins, in the condition of the study, were not able to fully capture 5FU whatever the dilution. The microbiological growth on BacT/ALERT® system after active carbon treatment was successfully confirmed with Staphylococcus aureus. Based on this validation results a method was then developed to routinely be able to perform sterility test of the batches produced and was confirmed on five microbiological species (i. e. S. aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans, Aspergillus brasiliensis). Our work gives a new insight for considering sterility testing by rapid microbiological method even for drugs exhibiting inhibitory effect on microbiological growth.

Download Full-text

The Ethylene Oxide Product Test of Sterility: Limitations and Interpretation of Results

Biomedical Instrumentation & Technology ◽

10.2345/0899-8205-55.s3.45 ◽

2021 ◽

Vol 55 (s3) ◽

pp. 45-56

Author(s):

Michael Sadowski ◽

Clark Houghtling ◽

Sopheak Srun ◽

Tim Carlson ◽

Jason Hedrick ◽

...

Keyword(s):

Ethylene Oxide ◽

False Negative ◽

Biological Indicator ◽

Detection Sensitivity ◽

Study Objective ◽

Sterility Testing ◽

Sterility Test ◽

Negative Results ◽

Frequency Detection ◽

Product Test

Abstract The ethylene oxide (EO) product test of sterility (ToS) can be conducted to comply with ANSI/AAMI/ISO 11135:2014 for the generation of data to demonstrate the appropriateness of the biological indicator (BI) that is used to develop and qualify the EO sterilization process. Clause D.8.6 of 11135 provides an option to perform a sublethal EO process, followed by conducting a product ToS, performing sterility testing of BIs from the process challenge device, and comparing the test results. Certain limitations for the EO product ToS should be considered when conducting studies that feature the use of this test, in order to support compliance with this requirement. Limitations for any sterility test include sample size, testing frequency, detection sensitivity, and/or the potential for false-positive/false-negative results, each of which must be recognized and well understood in order to support compliance with the standard. In addition, the experimental design of any study featuring the use of a sterility test should be carefully developed to ensure the generation of scientifically sound results and conclusions to support the study objective.

Download Full-text

Development of next-generation sequencing-based sterility test

10.1101/2020.12.27.424516 ◽

2020 ◽

Author(s):

Jianhui Yue ◽

Chao Chen ◽

Xiaohuan Jing ◽

Qiwang Ma ◽

Bo Li ◽

...

Keyword(s):

Next Generation Sequencing ◽

Multiple Displacement Amplification ◽

High Sensitivity ◽

Next Generation ◽

Promising Alternative ◽

Sterility Testing ◽

Sterility Test ◽

Microorganism Identification ◽

Environmental Bacteria ◽

Generation Sequencing

AbstractThe sterility testing methods described in pharmacopoeias require an incubation period of 14 days to obtain analysis results. An alternative method that can significantly shorten the detection time and improve the accuracy is in urgent need to meet the sterility testing requirements of regenerative medicine products with a short shelf life. In this study, we developed the next-generation sequencing-based sterility test (NGSST) based on sequencing and multiple displacement amplification. The NGSST can be finished within 48 hours with five steps including whole genome amplification, sequencing, alignment, sterility testing report, and microorganism identification. We use RPKM ratio to minorize the influence of environmental bacteria and determine its cutoff based AUC curve. The NGSST showed high sensitivity in reporting contaminates at 0.1 CFU in supernatant of biological product or 1 CFU in cell suspension. Furthermore, we identified microorganisms in 5 primary umbilical cord mesenchymal stem cell samples that were tested positive by BacT/ALERTR 3D. Overall, the NGSST can serve as a promising alternative for sterility testing of biological products.

Download Full-text

The present state of aspirin and clopidogrel resistance

Hämostaseologie ◽

10.1055/s-0037-1617036 ◽

2009 ◽

Vol 29 (03) ◽

pp. 285-290 ◽

Cited By ~ 2

Author(s):

K. E. Guyer

Keyword(s):

Diagnostic Tests ◽

Arterial Thrombosis ◽

Cardiovascular Events ◽

Treatment Success ◽

Antiplatelet Agents ◽

Antiplatelet Drug ◽

Coronary Syndrome ◽

Testing Method ◽

Pharmacological Response ◽

Platelet Physiology

SummaryAntiplatelet therapy has demonstrated significant clinical benefit in the treatment of acute coronary syndrome. However, as with any treatment strategy it has been unable to prevent all cardiovascular events. This is far from surprising when considering the complexity of arterial thrombosis and more specifically platelet physiology. This lack of treatment success has provoked the introduction of various diagnostic tests and testing platforms with the intent of guiding and optimizing clinical treatment. Such tests have resulted in the generation of clinical data that suggest suboptimal response to antiplatelet agents such as aspirin and clopidogrel.In the case of both aspirin and clopidogrel, this suboptimal response has been termed resistance. Drug resistance would imply a lack of pharmacological response that has not been specifically investigated in many of the clinical studies performed to date. Rather, the term resistance has been used to describe various facets of platelet activation and aggregation relative to the testing method. Many of these measured parameters are not addressed in the therapeutic intent of the antiplatelet drug in question.

Download Full-text

Pengujian pada Aplikasi Penggajian Pegawai dengan menggunakan Metode Blackbox

Jurnal Informatika Universitas Pamulang ◽

10.32493/informatika.v5i1.4340 ◽

2020 ◽

Vol 5 (1) ◽

pp. 61

Author(s):

Vadlan Febrian ◽

Muhamad Rizki Ramadhan ◽

Muhammad Faisal ◽

Aries Saifudin

Keyword(s):

Data Entry ◽

Black Box ◽

Application Form ◽

Value Analysis ◽

Test Function ◽

Testing Method ◽

Black Box Testing ◽

Sample Testing ◽

Testing Techniques ◽

Program Error

In this employee payroll application, if there is an error program there will be a loss for employees and the company. Losses for employees, if this application program error occurs then the salary reduction will experience delays due to the difficulty in the process of calculating employee salaries and employees will be late in receiving salaries. Losses for the company, if there is an error program in this application, the company will suffer losses if the employee wants a salary reduction quickly but the company cannot calculate quickly and accurately. In solving this problem, the authors use the black box testing method. Black box testing method is a test that sees the results of execution through test data and ensures the function of the software. Black box testing method has several testing techniques, namely Sample Testing, Boundary Value Analysis, Equivalence Partitions and others. From the testing techniques that have been mentioned, we use the Equivalence Partitions testing technique. Equivalence Partitions are tests that refer to data entry on the employee payroll application form, input will be tested and then put together based on the test function, both valid and invalid values. The expected results of this test are a payroll system for employees who are computerized, have standard rules in the process of developing the program so that it is easy to develop and maintain, and can minimize errors in processing salary calculations for employees.

Download Full-text

Analisis Kesalahan Penggunaan Jinyici dalam Membuat Kalimat Bahasa Mandarin pada Mahasiswa Semester VI Angkatan 2014 Prodi Pendidikan Bahasa Mandarin Universitas Negeri Semarang

Longda Xiaokan: Journal of Mandarin Learning and Teaching ◽

10.15294/longdaxiaokan.v3i1.25899 ◽

2020 ◽

Vol 3 (1) ◽

Author(s):

Siti Soleha ◽

Fansi Onita Santoso ◽

Zaim Elmubarok

Keyword(s):

Language Education ◽

Quantitative Approach ◽

Education Department ◽

Testing Method ◽

Mandarin Language

Penelitian ini bertujuan untuk mengetahui besar persentase kesalahan penggunaan (jìnyìcí), mengetahui kesalahan apa saja yang dilakukan mahasiswa, menentukan cara untuk membedakan penggunaan (jìnyìcí) dan merumuskan solusi yang dapat dilakukan untuk mengurangi kesalahan penggunaan (jìnyìcí) tersebut. Pendekatan penelitian yang dilakukan adalah deskriptif kuantitatif. Populasi dan sampel pada penelitian ini adalah mahasiswa semester VI angkatan 2014 Prodi Pendidikan Bahasa Mandarin Universitas Negeri Semarang sebanyak 25 mahasiswa. Teknik pengumpulan data dilakukan dengan metode dokumentasi dan metode tes. Berdasarkan hasil penelitian diketahui persentase kesalahan penggunaan (jìnyìcí) adalah sebesar 28,4%. Kesalahan tersebut tergolong pada tingkat rendah, namun ada beberapa kesalahan yang perlu lebih diperhatikan yaitu kesalahan dalam penggunaan fungsi tata bahasa dan kesalahan dalam memahami makna. Cara membedakan penggunaan (jìnyìcí) dapat dilakukan mahasiswa dengan mempelajari fungsi tata bahasa kosakata (jìnyìcí) dan memahami makna kosakata (jìnyìcí). Solusi yang dapat dilakukan adalah mempelajari fungsi tata bahasa kosakata (jìnyìcí) secara keseluruhan dengan benar, memahami makna kosakata (jìnyìcí) secara spesifik, dan memperbanyak latihan membuat kalimat menggunakan kosakata (jìnyìcí).This study aims to identify mistake percentage in using (jìnyìcí), identify what mistakes conducted by students, determine how to differentiate the usage of (jìnyìcí), and formulate solution to reduce mistake in using (jìnyìcí). This study uses descriptive-quantitative approach. There are 25 sixth students of Mandarin Language Education Department in Universitas Negeri Semarang as population and sample. In addition, data is collected by documentation and testing method. Based on the analysis, there is 28,4% of mistake in using (jìnyìcí). This finding is categorized as low. However, there are some mistakes that need to be noted. For instance, mistake in using grammar and interpreting meaning. Furthermore, (jìnyìcí) can be differentiate by studying grammar of (jìnyìcí) and understand the meaning of (jìnyìcí). Finally, it is recommended to study the grammar of (jìnyìcí), specifically understand the meaning of (jìnyìcí) and increase the exercise to make sentences using (jìnyìcí).

Download Full-text