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87312

Validation of moist and dry heat processes used for sterilization and depyrogenation during ampoules manufacturing

Article

Last updated: 03 Jan 2025

Subjects

-

Tags

Pharmaceutics

Abstract

Pyrogens are fever-producing substances, which are metabolic products of microorganisms and most potent pyrogens are the endotoxins. Depyrogenation can be defined as the elimination of all pyrogenic substances which is an important part of the manufacture of sterile pyrogen free pharmaceutical products. This study compared between sterilization and depyrogenation using moist heat by autoclave, as well as dry heat. After incubation period (24 hours) at 55oC-60oC the color of Geobacillus stearothermophillus spores' control vial which didn't sterilized in autoclave changed from blue to yellow color representing the (+ve) result, while the other sterilized vials have no color change (-ve). In addition, all examined endotoxin containing ampoules showed gel formation (+ve) when examined by Limulus Amebocyte Lysate) LAL). All ampoule groups that have autoclaved for periods of 1 hour to 4 hours showed gel formation (+ve) after LAL test, while only the last group which have autoclaving periods of 5 hours (5 cycles) showed no gel formation (-ve). Sterility of vials that contained spores of Geobacillus stearothermophillus after dry heating at 250oC for 30 min showed no color change (-ve). In addition, LAL test for endotoxin containing ampoules after dry heating at 250oC for 30 min showed no gel formation representing -ve pyrogen. So, moist heat is effective in sterilization and not for depydrogenation, whereas, dry heat is effective in sterilization as well as for depyrogenation.

DOI

10.21608/jabps.2020.27282.1083

Keywords

sterilization, Dry and moist heat, Depyrogenation, Ampoule, Endotoxin

Authors

First Name

Ahmed

Last Name

Rashed

MiddleName

M.

Affiliation

Ultimate pharma Company, Alexandria, Egypt

Email

dr_elkomy2000@yahoo.com

City

Alexandria

Orcid

-

First Name

Ahmed

Last Name

Hetta

MiddleName

M.A.

Affiliation

Department of Botany and Microbiology, Faculty of Science, Minia University, 61519 Minia, Egypt

Email

ahmedhetta@gmail.com

City

Cairo

Orcid

-

First Name

Zeinab

Last Name

Hashem

MiddleName

S.

Affiliation

Department of Microbiology and Immunology, Faculty of Pharmacy, Minia University, 61519 Minia, Egypt

Email

zeinab.shawky@yahoo.com

City

El-Minia

Orcid

-

First Name

Mo'men

Last Name

El-Katatny

MiddleName

H.

Affiliation

Department of Botany and Microbiology, Faculty of Science, Minia University, 61519 Minia, Egypt

Email

melkatatny@hotmail.com

City

El-Minia

Orcid

-

Volume

3

Article Issue

3

Related Issue

14859

Issue Date

2020-07-01

Receive Date

2020-04-05

Publish Date

2020-07-01

Page Start

177

Page End

183

Print ISSN

2535-1869

Online ISSN

2535-2040

Link

https://jabps.journals.ekb.eg/article_87312.html

Detail API

https://jabps.journals.ekb.eg/service?article_code=87312

Order

5

Type

Original Article

Type Code

522

Publication Type

Journal

Publication Title

Journal of advanced Biomedical and Pharmaceutical Sciences

Publication Link

https://jabps.journals.ekb.eg/

MainTitle

Validation of moist and dry heat processes used for sterilization and depyrogenation during ampoules manufacturing

Details

Type

Article

Created At

22 Jan 2023