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185466

Determination of Microbial Recovery for some Pharmaceutical Raw Materials and Passive Monitoring at Production Area and Microbiology Laboratory at Egyptian Pharmaceutical Company

Article

Last updated: 03 Jan 2025

Subjects

-

Tags

Section E: Microbiology & Immunology

Abstract

Objective: This study aims to evaluate the validity of pharmaceutical raw materials obtained from an Egyptian pharmaceutical factory to ensure the accuracy of the examination findings before they are used in the manufacturing process. On the other hand, it also aims to determine the environmental microbial count at the microbiology laboratory and production areas to prevent microbial contamination during production and during microbiological analysis. Methods: Assessment of microbiological quality control according to pharmacopeia as plate method by using TSB media with a concentration of 0.1% tween 80, for passive monitoring using settled plate (TSA) media. Results: the percentage of microbial recovery for lactose monohydrate was 89%, 85%, 94%, 92%, 91%, and 91%, while Croscarmellose recorded 81%, 85%, 85%, 85%, and 88%, Mannitol recorded 86%, 85%, 91%, 83%, 86%, and 88%, Magnesium stearate recorded 91%, 85%, 94%, 89%, and 91%, and finally, Talc Powder recorded 94%, 85%, 94%, 91%, 87% and 85% for Pseudomonas aeruginosa, Salmonella enterica, Staphylococcus aureus, Candida albicans, Bacillus subtilis and Escherichia coli respectively for each pharmaceutical raw material. Methods of analysis recorded under acceptance criteria in the selected pharmaceutical factory according to pharmacopeia. On the other hand, the microbial quality of air for the production area selected by an Egyptian pharmaceutical company was under acceptance limits. Conclusion: All quality control methods and assessments of pharmaceutical raw materials, laboratories, and production areas must be performed to measure and control microbial contamination in the pharmaceutical industry and then produce high-quality pharmaceutical products free of microbial contamination, and methods of analysis must be recorded under acceptance criteria in the selected pharmaceutical factory according to pharmacopeia. On the other hand, the microbial quality of the air for the production area and microbiology laboratory that was selected by an Egyptian pharmaceutical company was under accepted limits. All quality control methods and assessments of pharmaceutical raw materials, laboratories, and production areas must be performed to measure and control microbial contamination in the pharmaceutical industry and then produce high-quality pharmaceutical products free of microbial contamination.

DOI

10.21608/aprh.2021.72862.1127

Keywords

microorganisms, Contamination, quality control, Pharmaceutical Industry, and recovery

Authors

First Name

Mohamed

Last Name

Mohamed

MiddleName

-

Affiliation

Sector of Research and Development, Department of Microbiology, Nile Company for Pharmaceutical and Chemical Industry, Cairo, Egypt.

Email

mohamednabil1986@yahoo.com

City

cairo

Orcid

-

First Name

Mohammed

Last Name

Azab

MiddleName

-

Affiliation

Botany and Microbiology Department, Faculty of Science, Al-Azhar University, Nasr City, Cairo, Egypt.

Email

-

City

-

Orcid

-

First Name

Amr

Last Name

Fouda

MiddleName

-

Affiliation

Botany and Microbiology Department, Faculty of Science, Al-Azhar University, Nasr City, Cairo, Egypt.

Email

-

City

-

Orcid

-

First Name

Saad El-Din

Last Name

Hassan

MiddleName

-

Affiliation

Botany and Microbiology Department, Faculty of Science, Al-Azhar University, Nasr City, Cairo, Egypt.

Email

-

City

-

Orcid

-

First Name

Salah

Last Name

Abdelbary

MiddleName

-

Affiliation

Botany and Microbiology Department, Faculty of Science, Al-Azhar University, Nasr City, Cairo, Egypt.

Email

-

City

-

Orcid

-

Volume

5

Article Issue

3

Related Issue

26911

Issue Date

2021-07-01

Receive Date

2021-04-18

Publish Date

2021-07-01

Page Start

327

Page End

335

Print ISSN

2357-0547

Online ISSN

2357-0539

Link

https://aprh.journals.ekb.eg/article_185466.html

Detail API

https://aprh.journals.ekb.eg/service?article_code=185466

Order

4

Type

Research Article

Type Code

318

Publication Type

Journal

Publication Title

Journal of Advanced Pharmacy Research

Publication Link

https://aprh.journals.ekb.eg/

MainTitle

Determination of Microbial Recovery for some Pharmaceutical Raw Materials and Passive Monitoring at Production Area and Microbiology Laboratory at Egyptian Pharmaceutical Company

Details

Type

Article

Created At

22 Jan 2023