Evaluation of microorganisms recovery capacity using Quantiswab to be implemented in environmental monitoring routine in Pharmaceutical industries facilities

Introduction: Microbiological control is crucial during biotechnological production processes.Environmental monitoring (EM) must be implemented in order to ensure regulatory requirements and these procedures might be carried out according to GMP.Effective methods should detect and quantify microorganisms located on surfaces and equipment.The introduction of Quantiswab on EM routine will allow sampling in hard to reach areas, improving the capacity of microorganisms recovery in production facilities, with higher precision and efficacy.To implement Quantiswab in routine, previous studies must be carried out aiming to evaluate wether the recovery, after sampling, meets specifications provided by the supplier and the EM program.Objectives: Implement a different environmental monitoring technique in pharmaceutical industries facilities, aiming surface with difficult access. Methodology:In the present study, nine microorganisms being seven ATCC strains and two in house strains, including Gram negatives, Gram positives, fungi and yeasts were used, at a concentration not greater than 10 3 CFU/mL (3 log 10 CFU/mL).Negative controls of Quantiswab and materials were used in the assay, as well as a positive control of microorganisms.All tests were taken in triplicate, in two different days.Recovery evaluation for direct plating technique was carried out inoculating 100 L of microbial suspension, directly in a Quantiswab which, then, was seed in plates with specific growth medium, and incubated for 3 days at (30 2,5) C for bacteria and 5 days at (27,5 2,5), for fungi and yeast.In elution buffer technique, 100 L of microbial suspension was inoculated in Quantiswab and after, it was placed into a tube containing 1 mL of a buffer solution.Then, it was mixed in vortex for 10 seconds to release the microorganisms from swab to the liquid.After that, 100 L of the buffer was inoculated in TSA and SDA plates, according to the microorganism, and incubated under pre-determined conditions.After the incubation period, the Colony Forming Units (CFU) were counted. Results:The direct plating technique assays showed an average recovery of microorganisms of 74%, while elution buffer technique indicates an average recovery of 107%.The results obtained were similar to the supplier results which were 60% and 90% for direct plating and elution buffer technique, respectively. Conclusion:Quantiswab is an effective tool to be applied in EM.The good recovery rate shows that this material could be integrated in EM routine, which provides an enlargement in sampling areas.This amplification will ensure safer and more efficient productive processes and therefore higher quality products.