STERILITY TESTING PROCEDURE OF OPHTHALMIC OCUSERT ACICLOVIR USED FOR TREATING HERPES 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.

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Decontamination and Validation of Isolators for Sterility Testing

Biomedical Instrumentation & Technology ◽

10.2345/0899-8205-50.s3.27 ◽

2016 ◽

Vol 50 (s3) ◽

pp. 27-33

Author(s):

Maria Luisa Bernuzzi

Keyword(s):

Hydrogen Peroxide ◽

Microbial Growth ◽

Microbial Contamination ◽

Operative Procedure ◽

False Negatives ◽

Typical Application ◽

Sterility Testing ◽

Integrity Verification ◽

Sterility Test ◽

Good Laboratory

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.

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Clinical Aspects of Bacterial Corneal Ulcer Prolonged Course, the Role of Herpes Viruses in Its Pathogenesis, Treatment

Ophthalmology in Russia ◽

10.18008/1816-5095-2019-1s-40-44 ◽

2019 ◽

Vol 16 (1S) ◽

pp. 40-44

Author(s):

V. V. Neroev ◽

L. A. Katargina ◽

L. A. Kovaleva ◽

G. I. Krichevskaya ◽

N. V. Balatskaya

Keyword(s):

Corneal Ulcer ◽

Human Herpesvirus ◽

Clinical Aspects ◽

Herpesvirus Type ◽

Corneal Ulcers ◽

Barr Virus ◽

Human Herpesvirus Type ◽

Epstein Barr ◽

Simplex Virus

Purpose: to study the role of human herpesviruses (HHV) in the pathogenesis of prolonged bacterial corneal ulcers. Patients and methods. 117 patients with bacterial corneal ulcer were examined. Two groups were identified: a favorable course-with duration of bacterial corneal ulcer epithelialization for 17 days (62 people) and a prolonged course with a persistent ulcer more than 17 days (55 people). Blood samples (n = 117) and scrapes from corneal ulcer (n = 117) were investigated in polymerase chain reaction (PCR) for the presence of deoxyribonucleic acid (DNA) of Herpes simplex virus (HSV1, 2), Epstein-Barr virus (EBV), Human herpesvirus type 6, 7 (HHV-6, HSV-7). Results. The HSV1, 2 and EBV genomes were detected in the cornea significantly more often in BCU of prolonged course compared with a favorable course (HSV1, 2 p = 0.012; EBV p = 0.012), and HHV-6 was detected not only in the cornea (p = 0.000), but also and in blood (p = 0.007). In patients with HHV DNA in corneal scarps and/or blood, after resorption of purulent infiltrate, corneal epithelialization was absent, and the use of antiherpetic drugs allowed to reduce the completion time of BCU epithelialization. Conclusion. The role of HHV-6, EBV, HSV 1, 2 in the pathogenesis of bacterial corneal ulcer of protracted course was revealed. The expediency of examination of patients with bacterial corneal ulcer on HHV is shown, a method of treatment is proposed, including antiherpetic therapy, which makes it possible to prevent the development of a protracted course.

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Microbial Agents Causing Infective Corneal Ulcer and their Anti-microbial Susceptibility pattern

Bangladesh Medical Journal ◽

10.3329/bmj.v47i2.43502 ◽

2019 ◽

Vol 47 (2) ◽

pp. 1-6

Author(s):

Azima Aktar Jhuma ◽

Md Moynul Haque ◽

Jamil Ahmed ◽

Shantanu Das ◽

Tarun Kanti Paul ◽

...

Keyword(s):

Antimicrobial Susceptibility ◽

Staphylococcus Epidermidis ◽

Microbial Growth ◽

Corneal Ulcer ◽

Bacterial Pathogen ◽

Fungal Growth ◽

Penicillium Species ◽

Corneal Ulcers ◽

Microbial Agents ◽

Susceptibility Patterns

This study was designed to identify the microbial agents causing infective corneal ulcer and to carry out the antimicrobial susceptibility patterns of isolated bacteria causing infective corneal ulcer. Out of 80 samples, 67 (83.75%) cases were positive by microscopy and culture. This study showed pure fungal growth in 39 (48.75%) cases, pure bacterial growth in 8 (10%) cases, mixed microbial growth (both fungi and bacteria) in 20 (25%) cases and no growth was observed in 13 (16.25%) cases. Among the fungal isolates, Aspergillus species was the leading agent detected in 37(46.3%) cases followed by Penicillium species in 7 (8.8%) instances. Pseudomonas aeruginosa was the most common bacterial pathogen found in 11 (13.8%) cases followed by Staphylococcus epidermidis present in 9 (11.3%) cases. Gentamicin, Ciprofloxacin and Levofloxacin were found to be better efficacious drugs against most of the bacterial pathogens noted in antimicrobial susceptibility test. This study showed that infective corneal ulcers are caused by both bacterial and fungal agents but fungal agents are more common. The findings of this study would help the ophthal- mologists in evidence based management of their patients of infective corneal ulcer. Bangladesh Med J. 2018 May; 47 (2): 1-6

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Human CD4+ CD25high Cells Suppress Proliferative Memory Lymphocyte Responses to Herpes Simplex Virus Type 2

Journal of Virology ◽

10.1128/jvi.00656-06 ◽

2006 ◽

Vol 80 (16) ◽

pp. 8271-8273 ◽

Cited By ~ 24

Author(s):

George A. Diaz ◽

David M. Koelle

Keyword(s):

Herpes Simplex Virus ◽

Herpes Simplex ◽

Virus Type ◽

Herpes Simplex Virus Type ◽

Autologous Blood ◽

Suppressive Effect ◽

Corneal Damage ◽

Simplex Virus ◽

Lymphocyte Responses

ABSTRACT Lymphocytes with the regulatory CD4+ CD25+ phenotype frequently suppress memory T-cell responses. Murine herpes simplex virus type 1 (HSV-1) models have shown that CD4+ CD25+ cells can limit immunity-mediated corneal damage but slow viral clearance. We investigated the effect of CD4+ CD25+ cells from healthy HSV-2-infected humans on recall proliferative (CD4) responses to HSV-2. Depletion and reconstitution experiments were consistent with a suppressive effect of autologous blood-derived CD4+ CD25+ cells for whole HSV-2 antigen. Regulatory T cells may modulate human CD4 memory responses to HSV-2 and influence their antiviral and inflammatory functions.

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

Journal of Pharmaceutical Innovation ◽

10.1007/s12247-017-9303-z ◽

2017 ◽

Vol 13 (1) ◽

pp. 27-35 ◽

Cited By ~ 5

Author(s):

Adriana Bugno ◽

Deborah Pita Sanches Saes ◽

Adriana Aparecida Buzzo Almodovar ◽

Kamal Dua ◽

Rajendra Awasthi ◽

...

Keyword(s):

Sterility Testing ◽

Sterility Test ◽

Testing Method

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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.

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Herpes Simplex Virus-Induced Ocular Diseases: Detrimental Interaction Between Virus and Host

Current Immunology Reviews ◽

10.2174/157339511796196557 ◽

2011 ◽

Vol 7 (3) ◽

pp. 310-327 ◽

Cited By ~ 4

Author(s):

Georges M.G.M. Verjans ◽

Arnd Heiligenhaus

Keyword(s):

Herpes Simplex Virus ◽

Herpes Simplex ◽

Ocular Diseases ◽

Simplex Virus

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A New Rapid Immunoperoxidase Diagnostic Staining of Herpes Simplex Virus 1 Indolent Corneal Ulcer

Cornea ◽

10.1097/00003226-198402000-00007 ◽

1984 ◽

Vol 3 (2) ◽

pp. 115???118 ◽

Cited By ~ 4

Author(s):

Mary Ann Duke ◽

Robert M. Webb ◽

Robert A. Catalano

Keyword(s):

Herpes Simplex Virus ◽

Herpes Simplex ◽

Corneal Ulcer ◽

Herpes Simplex Virus 1 ◽

Simplex Virus

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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.

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