Sterility Test | ScienceGate

Objective: The present research has been undertaken for the formulation and evaluation of Benzoyl Peroxide Injection. It is used for Antiacne activity. Methods: Benzoyl peroxide is used as Antiacne. Methyl paraben, Propyl paraben and benzalkoniumchloride were used as preservatives. Water for injection is used as a vehicle. The following parameters were evaluated such as clarity test, leakage test, chearity test, assay and Sterility test. Results: The clearity test shows clear solution. Drug chearity test shows no chear in the vials. Leakage test shows no leakage in the vials. pH and drug content show the F1 batch was better the other batches. IR confirmed that all functional groups are same as benzoyl Peroxide. Conclusion: It was concluded that F1 batch is the good than the other batches. So F1 batch is good for the Parenteral use.

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STERILITY TEST FOR PENICILLIN

Science ◽

10.1126/science.98.2549.413 ◽

1943 ◽

Vol 98 (2549) ◽

pp. 413-414 ◽

Cited By ~ 7

Author(s):

C. A. LAWRENCE

Keyword(s):

Sterility Test

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Sterility test on water oil emulsions

Antonie van Leeuwenhoek ◽

10.1007/bf02543718 ◽

1954 ◽

Vol 20 (1) ◽

pp. 167-173

Author(s):

E. Hertzberger

Keyword(s):

Sterility Test ◽

Oil Emulsions

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Detection of bacterial adenosine triphosphate through bioluminescence, applied to a rapid sterility test of injectable preparations

Analytica Chimica Acta ◽

10.1016/0003-2670(91)80078-8 ◽

1991 ◽

Vol 255 (2) ◽

pp. 423-425 ◽

Cited By ~ 2

Author(s):

A. Decool ◽

V. Goury ◽

A. Tibi ◽

S. Gibaud ◽

F. Vincent ◽

...

Keyword(s):

Adenosine Triphosphate ◽

Sterility Test

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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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