Culturable microbiological profile of a non-sterile drugs pharmaceutical production environment

Soares, Gustavo; Amorim-Neto, Dionísio Pedro; Cogo-Müller, Karina

doi:10.1590/s2175-97902024e23664

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Brazilian Journal of Pharmaceutical Sciences

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Article • Braz. J. Pharm. Sci. 60 • 2024 • https://doi.org/10.1590/s2175-97902024e23664 copy

Culturable microbiological profile of a non-sterile drugs pharmaceutical production environment

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

For places where non-sterile drug production occurs, regulatory bodies recommend monitoring of the environmental bioburden. This procedure provides information regarding possible microbiological risks to which the products may be exposed, so that subsequent action measures may be implemented. The aim of the present work was to quantify and characterize the microorganisms present in Grade D (ISO 8) cleanrooms of a Brazilian pharmaceutical industry, identifying any possible seasonal climatic influences on these environments. Sampling was performed by surface and air monitoring, over 12 months during the year 2019, in rooms that were in operation. For both sampling methods, no statistically significant differences in bacteria and fungi counts were found between months or seasonal periods. Microorganisms that presented higher incidence included Staphylococcus epidermidis (15%) and Micrococcus spp. (13%), common to the human microbiota, and the fungi Cladosporium sp. (23%) and Penicillium sp. (21%), typical of the external environment. The results showed that microbial contamination in the Grade D cleanrooms was within the permissible maximum levels and remained similar throughout the year. Microbiological quality control in the clean areas of the pharmaceutical industry investigated was considered effective, with regular maintenance being necessary to keep bioburden levels controlled.

Keywords:
Microbiota; environmental monitoring; cleanroom; airborne microbes; indoor air; microbiological air quality

	Total			Bacteria			Fungi
	CFUs	IDs	%	CFUs	IDs	%	CFUs	IDs	%
January	265	100	37,7%	202	79	39,1%	63	21	33,3%
February	351	106	30,2%	223	74	33,2%	128	32	25,0%
March	453	132	29,1%	321	88	27,4%	132	44	33,3%
April	373	105	28,2%	235	96	40,9%	138	9	6,5%
May	562	138	24,6%	385	115	29,9%	177	23	13,0%
June	292	126	43,2%	159	82	51,6%	133	44	33,1%
July	279	111	39,8%	189	76	40,2%	90	35	38,9%
August	282	130	46,1%	192	97	50,5%	90	33	36,7%
September	188	112	59,6%	133	75	56,4%	55	37	67,3%
October	200	126	63,0%	118	85	72,0%	82	41	50,0%
November	156	88	56,4%	118	63	53,4%	38	25	65,8%
December	157	65	41,4%	127	45	35,4%	30	20	66,7%
TOTAL	3558	1339	37,6%	2402	975	40,6%	1156	364	31,5%

Month	Microorganism	IDs	%	Month	Microorganism	IDs	%
January	Micrococcus spp.	13	16,5%	July	Micrococcus spp.	16	21,1%
	Staphylococcus hominis	7	8,9%		Staphylococcus epidermidis	12	15,8%
	Staphylococcus haemolyticus	7	8,9%		Staphylococcus warneri	6	7,9%
	Staphylococcus epidermidis	7	8,9%		Bacillus firmus	4	5,3%
	Staphylococcus capitis	5	6,3%		Bacillus megaterium	4	5,3%
	6th onwards	40	50,6%		6th onwards	34	44,7%
February	Staphylococcus simulans	12	16,2%	August	Staphylococcus epidermidis	21	21,6%
	Bacillus pumilus	10	13,5%		Bacillus firmus	11	11,3%
	Micrococcus lylae	9	12,2%		Micrococcus spp.	9	9,3%
	Staphylococcus epidermidis	6	8,1%		Staphylococcus warneri	8	8,2%
	Staphylococcus warneri	4	5,4%		Staphylococcus xylosus	6	6,2%
	6th onwards	33	44,6%		6th onwards	42	43,3%
March	Staphylococcus epidermidis	13	14,8%	September	Staphylococcus epidermidis	13	17,3%
	Micrococcus lylae	11	12,5%		Micrococcus spp.	13	17,3%
	Staphylococcus simulans	6	6,8%		Bacillus circulans	8	10,7%
	Bacillus megaterium	5	5,7%		Sphingomonas paucimobilis	5	6,7%
	Bacillus sphaericus	4	4,5%		Bacillus lentus	5	6,7%
	6th onwards	49	55,7%		6th onwards	31	41,3%
April	Micrococcus spp.	20	20,8%	October	Micrococcus spp.	14	16,5%
	Staphylococcus epidermidis	12	12,5%		Staphylococcus epidermidis	13	15,3%
	Staphylococcus capitis	4	4,2%		Staphylococcus xylosus	8	9,4%
	Bacillus megaterium	4	4,2%		Sphingomonas paucimobilis	6	7,1%
	Staphylococcus cohnii ssp cohnii	4	4,2%		Staphylococcus hominis	5	5,9%
	6th onwards	52	54,2%		6th onwards	39	45,9%
May	Staphylococcus epidermidis	18	15,7%	November	Staphylococcus epidermidis	11	17,5%
	Micrococcus spp.	16	13,9%		Micrococcus spp.	10	15,9%
	Bacillus circulans	10	8,7%		Bacillus megaterium	6	9,5%
	Staphylococcus xylosus	10	8,7%		Staphylococcus hominis	5	7,9%
	Bacillus lentus	9	7,8%		Bacillus circulans	5	7,9%
	6th onwards	52	45,2%		6th onwards	26	41,3%
June	Staphylococcus epidermidis	13	15,9%	December	Micrococcus spp.	11	24,4%
	Bacillus megaterium	11	13,4%		Staphylococcus epidermidis	5	11,1%
	Staphylococcus warneri	5	6,1%		Bacillus lentus	5	11,1%
	Micrococcus spp.	4	4,9%		Staphylococcus capitis	4	8,9%
	Staphylococcus xylosus	4	4,9%		Bacillus firmus	3	6,7%
	6th onwards	45	54,9%		6th onwards	17	37,8%

Month	Microorganism	IDs	%	Month	Microorganism	IDs	%
January	Cladosporium sp.	7	33,3%	July	Cladosporium sp.	7	20,0%
	Penicillium sp.	5	23,8%		Alternaria sp.	6	17,1%
	Aspergillus sp.	3	14,3%		Penicillium sp.	5	14,3%
	Alternaria sp.	2	9,5%		Curvularia sp.	5	14,3%
	Neurospora sp.	1	4,8%		Mycelia sterilia	3	8,6%
	6th onwards	3	14,3%		6th onwards	9	25,7%
February	Alternaria sp.	7	21,9%	August	Penicillium sp.	9	27,3%
	Neurospora sp.	5	15,6%		Curvularia sp.	7	21,2%
	Curvularia sp.	5	15,6%		Cladosporium sp.	6	18,2%
	Mycelia sterilia	5	15,6%		Alternaria sp.	3	9,1%
	Penicillium sp.	4	12,5%		Mycelia sterilia	2	6,1%
	6th onwards	6	18,8%		6th onwards	6	18,2%
March	Cladosporium sp.	14	31,8%	September	Curvularia sp.	7	18,9%
	Penicillium sp.	8	18,2%		Cladosporium sp.	7	18,9%
	Mycelia sterilia	6	13,6%		Penicillium sp.	5	13,5%
	Aspergillus sp.	4	9,1%		Aspergillus sp.	5	13,5%
	Alternaria sp.	4	9,1%		Mycelia sterilia	5	13,5%
	6th onwards	8	18,2%		6th onwards	8	21,6%
April	Aspergillus sp.	2	22,2%	October	Penicillium sp.	15	36,6%
	Verticillium sp.	2	22,2%		Cladosporium sp.	8	19,5%
	Alternaria sp.	2	22,2%		Curvularia sp.	8	19,5%
	Penicillium sp.	1	11,1%		Alternaria sp.	6	14,6%
	Curvularia sp.	1	11,1%		Aspergillus sp.	2	4,9%
	6th onwards	1	11,1%		6th onwards	2	4,9%
May	Cladosporium sp.	10	43,5%	November	Penicillium sp.	9	36,0%
	Penicillium sp.	4	17,4%		Cladosporium sp.	6	24,0%
	Aspergillus sp.	2	8,7%		Alternaria sp.	5	20,0%
	Verticillium sp.	2	8,7%		Trichoderma sp.	2	8,0%
	Alternaria sp.	1	4,3%		Aspergillus sp.	1	4,0%
	6th onwards	4	17,4%		6th onwards	2	8,0%
June	Penicillium sp.	10	22,7%	December	Cladosporium sp.	7	35,0%
	Cladosporium sp.	10	22,7%		Alternaria sp.	4	20,0%
	Curvularia sp.	9	20,5%		Curvularia sp.	4	20,0%
	Mycelia sterilia	5	11,4%		Trichoderma sp.	2	10,0%
	Aspergillus sp.	3	6,8%		Verticillium sp.	1	5,0%
	6th onwards	7	15,9%		6th onwards	2	10,0%

Universidade de São Paulo, Faculdade de Ciências Farmacêuticas Av. Prof. Lineu Prestes, n. 580, 05508-000 S. Paulo/SP Brasil, Tel.: (55 11) 3091-3824 - São Paulo - SP - Brazil
E-mail: bjps@usp.br

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[1] *Correspondence: K. Cogo-Müller. Faculdade de Ciências Farmacêuticas. Universidade Estadual de Campinas. Rua Cândido Portinari, 200, Bairro Vila Nogueira. Campinas, SP, 13083-871, Brazil. Phone: +55 (19) 3521-8144. E-mail: karina.muller@fcf.unicamp.br.