Application of the BacT/ALERT&lt;sup&gt;R&lt;/sup&gt; 3D system for sterility testing of injectable products

Bugno, Adriana; Lira, Rodolfo Santos de; Oliveira, Wesley Anderson de; Almodóvar, Adriana Aparecida Buzzo; Saes, Deborah Pita Sanches; Pinto, Terezinha de Jesus Andreoli

doi:10.1590/s1517-838246320140587

Cited by 20 publications

(15 citation statements)

References 13 publications

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“…The testing of biological samples, injectable and blood products by the conventional BacT/ALERT 3D system, based on the processing of diagnostic blood cultures, has previously been analyzed by other groups [2,9,13,15,17,[21][22][23][24]. However, these studies involved high incubation temperatures adapted to primarily human pathogens and no process contaminants caused by handling and processing of the product.…”

Section: Discussionmentioning

confidence: 99%

“…Sterility testing is one of the most well-established microbiological tests in pharmaceutical quality control. Methods for sterility testing were first introduced by the British Pharmacopeia in 1932 as direct inoculation of the test product to liquid culture media [2]. As an alternative method, membrane filtration was introduced in the late 1960s in other pharmacopoeias [3,4].…”

Section: Introductionmentioning

confidence: 99%

“…Several rapid microbiological methods for the detection of microorganisms used for sterility testing purposes have been evaluated in recent years [2,[11][12][13][14][15]. Experts agree widely that the use of automated sterility testing systems could enable more rapid and more reliable detection of microbial contamination by using specific indicators and consequent automated analysis for the detection of microbial growth [16].…”

Section: Introductionmentioning

confidence: 99%

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Microbiological Control of Cellular Products: The Relevance of the Cellular Matrix, Incubation Temperature, and Atmosphere for the Detection Performance of Automated Culture Systems

Günther

Geiß

Kaiser

et al. 2019

Transfus Med Hemother

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Background: The microbiological control of cellular products sometimes causes significant procedural issues for quality control laboratories. According to the European Pharmacopoeia (EP), the microbiological control of cellular products requires a 7-to 14-day incubation period at two different incubation temperatures using aerobic and anaerobic growth media. However, the suitability of these test conditions for efficient quality control can be influenced by many conditions, such as the expected microbial spectrum of contamination or the texture and composition of the cellular product. Because of interference, direct inoculation and membrane filtration as reference methods of pharmacopoeia are largely unsuitable for the microbiological control of cellular products; therefore, alternative and, above all, automated methods are the focus of interest. Objective: The aim of our study was to evaluate the method suitability and possible effects of cell matrix, incubation temperature, and oxy-

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Microbiological Control of Cellular Products: The Relevance of the Cellular Matrix, Incubation Temperature, and Atmosphere for the Detection Performance of Automated Culture Systems

Günther

Geiß

Kaiser

et al. 2019

Transfus Med Hemother

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“…7. Take a sample with a syringe to test the absence of fibrinogen and perform a sterility test for aerobic and anaerobic bacterial cultures 17 . Label the tubes appropriately and freeze them at -20 °C until usage.…”

Section: Preparation Of the Autologous Serummentioning

confidence: 99%

Mesenchymal Stromal Cell Culture and Delivery in Autologous Conditions: A Smart Approach for Orthopedic Applications

Trombi

Danti

Savelli

et al. 2016

JoVE

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Human Mesenchymal Stromal Cells (hMSCs) are cultured in vitro with different media. Limits on their use in clinical settings, however, mainly depend on potential biohazard and inflammation risks exerted by xenogeneic nutrients for their culture. Human derivatives or recombinant materials are the first choice candidates to reduce these reactions. Therefore, culture supplements and materials of autologous origin represent the best nutrients and the safest products.Here, we describe a new protocol for the isolation and culture of bone marrow hMSCs in autologous conditions -namely, patient-derived serum as a supplement for the culture medium and fibrin as a scaffold for hMSC administration. Indeed, hMSC/fibrin clot constructs could be extremely useful for several clinical applications. In particular, we focus on their use in orthopedic surgery, where the fibrin clot derived from the donor's own blood allowed effective cell delivery and nutrient/waste exchanges. To ensure optimal safety conditions, it is of the utmost importance to avoid the risks of hMSC transformation and tissue overgrowth. For these reasons, the approach described in this paper also indicates a minimally ex vivo hMSC expansion, to reduce cell senescence and morphologic changes, and short-term osteo-differentiation before implantation, to induce osteogenic lineage specification, thus decreasing the risk of subsequent uncontrolled proliferation.

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“…Another rapid sterility testing has also been developed elsewhere, which employs a combination of direct fluorescent labeling techniques and solid-phase laser scanning cytometry to rapidly enumerate viable microorganisms from aqueous samples. Besides, there are still several new innovation of sterility testing systems which has been validated [22][23][24][25].…”

Section: Introductionmentioning

confidence: 99%

Effect of Radioactivity of Technetium-99m on the Autosterilization Process of non-sterile Tetrofosmin Kits

Widyastuti

Lestari

Sangaji

2017

J. Pure App. Chem. Res.

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Technetium-99m labeled radiopharmaceutical is commonly used in nuclear medicines as a diagnostic agent, by mixing the sterile kit with Tc-99m. Manufacturing of kits requires an aseptic facility which need to be well designed and maintained according to cGMP, since mostly kits can not be terminally sterilized. Radiopharmaceuticals as pharmaceuticals containing radionuclide is assumed to have an autosterilization property, but correlation between radioactivity and capability of killing microorganisms has to be studied so far. The aim of this study is to investigate the effect of radioactivity on the autosterilization process of radiopharmaceuticals. The study was carried out by adding Tc-99m of various radioactivity into non-sterile tetrofosmin kits, then the samples were tested for sterility. Sterile tetrofosmin kit and non-sterile kit with no Tc-99m added will be used as a negative control and positive control respectively. The sterility was tested using standard direct inoculation method, by inoculating samples in culture media for both bacteria and fungi and observing qualitatively within 14 days. The results showed that the samples with radioactivity of 1, 3 and 5 mCi changed the clarity of the media to turbid, conformed with the performance of positive controls but samples with radioactivity of 10 mCi and 20 mCi did not change the clarity of the media, conformed with the performance of negative control, indicating neither growth of bacteria nor fungi. It is concluded that Tc-99m behaves as an autosterilizing agent at certain radioactivity. Therefore the preparation of Tc99m radiopharmaceutical can be considered as terminal sterilization rather than aseptic preparation.

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Application of the BacT/ALERT<sup>R</sup> 3D system for sterility testing of injectable products

Cited by 20 publications

References 13 publications

Microbiological Control of Cellular Products: The Relevance of the Cellular Matrix, Incubation Temperature, and Atmosphere for the Detection Performance of Automated Culture Systems

Microbiological Control of Cellular Products: The Relevance of the Cellular Matrix, Incubation Temperature, and Atmosphere for the Detection Performance of Automated Culture Systems

Mesenchymal Stromal Cell Culture and Delivery in Autologous Conditions: A Smart Approach for Orthopedic Applications

Effect of Radioactivity of Technetium-99m on the Autosterilization Process of non-sterile Tetrofosmin Kits

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