دورية أكاديمية
Quantitative and qualitative evaluation of microorganism profile identified in bioburden analysis in a biopharmaceutical facility in Brazil: Criteria for classification and management of results.
| العنوان: | Quantitative and qualitative evaluation of microorganism profile identified in bioburden analysis in a biopharmaceutical facility in Brazil: Criteria for classification and management of results. |
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| المؤلفون: | Mattoso JMV; Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil., Costa LV; Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil., Vale BA; Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil., Reis CMF; Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil., Andrade JM; Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil., Braga LMPS; Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil., Conceição GMS; Documentation Section, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil., Costa PBM; Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil., Silva IB; Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil., Rodrigues LAP; Centro Universitário SENAI CIMATEC, Salvador/BA, Brazil., Anjos JP; Centro Universitário SENAI CIMATEC, Salvador/BA, Brazil., Brandão MLL; Laboratory of Microbiology Control, Department of Quality Control, Bio-Manguinhos/Fiocruz, Rio de Janeiro/RJ, Brazil; marcelo.brandao@bio.fiocruz.br. |
| المصدر: | PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2024 Jun 28. Date of Electronic Publication: 2024 Jun 28. |
| Publication Model: | Ahead of Print |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Pda (Parenteral Drug Association) Country of Publication: United States NLM ID: 9439538 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1948-2124 (Electronic) Linking ISSN: 10797440 NLM ISO Abbreviation: PDA J Pharm Sci Technol Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Bethesda Md : Pda (Parenteral Drug Association) |
| مستخلص: | Microbiological contamination may cause microbial proliferation and consequently additional problems for pharmaceutical companies through production stoppage, product contamination, investigations of process deviations, out-of-specification results and product disposal. This is one of the major concerns of the regulatory health agencies. Microbiological load (bioburden) may represent a potential risk for patients if the sterilization process is not effective and/or due to the production of toxins. Although bioburden can be eliminated by terminal sterilization or filtration processes, it is important to monitor the amount and determine the identity and characteristics of the microorganisms present prior to final processing. The application of microorganism identification systems is crucial for identifying the type of contamination, which can be extremely useful for investigating. The aim of this study was to evaluate the profiles of microorganisms identified in bioburden assays from solutions, culture medias, and products (SCP) from a pharmaceutical industry facility. From 2018-2020, a total of 1,078 samples from 857 different lots of SCP were analyzed and isolated microorganisms were identified. A prefiltering step was included after March 2020, in order to reduce the bioburden before sterilizing filtration. Criteria for the definition and management of microorganisms identified were evaluated after an integrative bibliographic review, and three groups were proposed (critical, objectionable, and nonobjectionable microorganisms). For the samples that did not include prefiltering (n=636), 227 (35.7%) presented microbial growth. For those that included prefiltering, before prefiltering (n=221), 60.6% presented microbial growth, and after prefiltering, this value was reduced to 4.1%, which can be attributed to a contamination during the sampling or a wrong filtering. From the samples that presented microbial growth, 678 microorganisms were identified as bacteria and 59 as molds and yeasts. A total of 120 microorganisms (56 and 27 Gram-positive and negative bacteria, respectively, 31 yeasts, and six filamentous molds) could not be identified, and the remaining microorganisms were classified as objectionable (n=507; 82.2%), nonobjectionable (n=103; 16.7%) and critical (n=7; 1.1%). Most of the bioburden species (>80.0%) were considered objectionable microorganisms. A process for classification and management of bioburden analysis results based on a literature review of pathogenic and physiological characteristics of the microorganisms was proposed. (Copyright © 2024, Parenteral Drug Association.) |
| فهرسة مساهمة: | Keywords: Pharmaceutical facility; bioburden; contamination control strategy; identification; microbial contamination; quality control |
| تواريخ الأحداث: | Date Created: 20240628 Latest Revision: 20240628 |
| رمز التحديث: | 20240629 |
| DOI: | 10.5731/pdajpst.2023.012883 |
| PMID: | 38942484 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1948-2124 |
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| DOI: | 10.5731/pdajpst.2023.012883 |