Sterilization Processes in the Pharmaceutical Industry

Armenante, Piero M.; Akiti, Otute

doi:10.1002/9781119600800.ch64

Cited by 11 publications

(14 citation statements)

References 23 publications

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“…Among the environmental factors of space travel, chronic exposure to radiation is possibly the main additional contributor to instability of pharmaceutical products. Although gamma radiation and X-rays are commonly used to sterilize pharmaceuticals on Earth ( Armenante and Akiti, 2019 ), space radiation differs from the radiation used in these processes in the type of radiation, dose, dose-rate and exposure time. Direct ionization is radiation that strikes a target molecule and can cause the rupture of chemical bonds and the destruction of polymer structure ( Kempner, 2001 ).…”

Section: The Current State Of Medicines In Spacementioning

confidence: 99%

To infinity and beyond: Strategies for fabricating medicines in outer space

Seoane-Viaño¹,

Ong²,

Basit³

et al. 2022

International Journal of Pharmaceutics: X

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Section: The Current State Of Medicines In Spacementioning

confidence: 99%

To infinity and beyond: Strategies for fabricating medicines in outer space

Seoane-Viaño¹,

Ong²,

Basit³

et al. 2022

International Journal of Pharmaceutics: X

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“…Biotechnological processes routinely require sterile environments, which means that all equipment, materials, and substrates used should be free of any microbial contamination. The process of destroying, inactivating, or permanently removing all microorganisms by physicochemical methods, is defined as sterilization [ 1 ]. Sterilization processes are divided into four main categories, i.e., heat, radiation, chemical, and sterile filtration.…”

Section: Introductionmentioning

confidence: 99%

The Effect of Heat Sterilization on Key Filtration Performance Parameters of a Commercial Polymeric (PVDF) Hollow-Fiber Ultrafiltration Membrane

et al. 2022

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Membrane processes can be integrated with fermentation for the selective separation of the products from the fermentation broth. Sterilization with saturated steam under pressure is the most widely used method; however, data concerning heat sterilization applicability to polymeric ultrafiltration (UF) membranes are scarcely available. In this study, the effect of the sterilization process on the filtration performance of a commercial polyvinylidene difluoride (PVDF) hollow fiber UF membrane was evaluated. Membrane modules were constructed and sterilized several times in an autoclave. Pure water flux tests were performed, to assess the effect of heat sterilization on the membrane’s pure water permeance. Dextran rejection tests were performed for the characterization of membrane typical pore size and its fouling propensity. Filtration performance was also assessed by conducting filtration tests with real fermentation broth. After repeated sterilization cycles, pure water permeance remained quite constant, varying between approx. 830 and 990 L·m−2·h−1·bar−1, while the molecular weight cut-off (MWCO) was estimated to be in the range of 31.5–98.0 kDa. Regarding fouling behavior, the trans-membrane pressure increase rate was stable and quite low (between 0.5 and 7.0 mbar/min). The results suggest that commercial PVDF UF membranes are a viable alternative to high-cost ceramic UF membranes for fermentation processes that require heat sterilization.

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“…Accordingly, spore inactivation is of high relevance in a multitude of industries and contexts. Unfortunately, highly resistant spores pose a challenge in inactivation processes ( 2 , 3 ). Intensive heat treatment is commonly applied to inactivate dormant spores; however, this treatment is associated with a significant loss in important quality attributes, such as nutritional value, color, or taste in the food sector or heat-labile active ingredients in the pharmaceutical and biotechnological sectors ( 3 , 4 ).…”

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confidence: 99%

“…Unfortunately, highly resistant spores pose a challenge in inactivation processes ( 2 , 3 ). Intensive heat treatment is commonly applied to inactivate dormant spores; however, this treatment is associated with a significant loss in important quality attributes, such as nutritional value, color, or taste in the food sector or heat-labile active ingredients in the pharmaceutical and biotechnological sectors ( 3 , 4 ). The scientific and industrial community therefore require cost-effective strategies that mildly inactivate spores to retain important quality attributes.…”

mentioning

confidence: 99%

“…Eradication of spores would allow for shelf-stable storage of a multitude of products that currently need cooling to avoid spore outgrowth, which is not only a logistical challenge but also an environmental burden ( 13 ). (ii) A second application is the sterilization of liquid or gel-like, heat-labile pharmaceuticals that are not suitable for sterile filtration while maintaining the activity of sensitive compounds ( 3 ). (iii) A third application is the sterilization of bones, cartilage, and tendon ex vivo while leaving the mechanical properties of the tissues unimpaired, thus allowing reimplantation of the resected tissue explants ( 15 ).…”

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confidence: 99%

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Moderate High-Pressure Superdormancy in Bacillus Spores: Properties of Superdormant Spores and Proteins Potentially Influencing Moderate High-Pressure Germination

Delbrück

Tritten

Nanni

et al. 2022

Appl Environ Microbiol

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Resistant bacterial spores are a major concern in industrial decontamination processes. An approach known as pressure-mediated germination-inactivation strategy aims to artificially germinate spores by pressure to mitigate their resistance to inactivation processes. The successful implementation of such a germination-inactivation strategy relies on the germination of all spores. However, germination is heterogeneous, with some ‘superdormant’ spores germinating extremely slowly or not at all. The present study investigated potential underlying reasons for moderate high-pressure (150 MPa, 37°C) superdormancy of Bacillus subtilis spores. The water and dipicolinic acid content of superdormant spores was compared to that of the initial dormant spore population. The results suggest that water and dipicolinic acid content are not major drivers of moderate high-pressure superdormancy. Proteomic analysis was used to identify proteins that were quantified at significantly different levels in superdormant spores. Subsequent validation of the germination capacity of deletion mutants revealed that the presence of protein YhcN is required for efficient moderate high-pressure germination and that proteins MinC, cse60, and SspK may also play a role, albeit a minor one. Importance Spore-forming bacteria are ubiquitous in nature, and as a consequence, inevitably enter the food chain or other processing environments. Their presence can lead to significant spoilage or safety related issues. Intensive treatment is usually required to inactivate them; however, this harms important quality attributes. A pressure-mediated germination-inactivation approach can balance the need for effective spore inactivation and retention of sensitive ingredients. However, superdormant spores are the bottleneck preventing the successful and safe implementation of such a strategy. In-depth understanding of moderate high-pressure germination and the underlying causes of superdormancy is necessary to advance the development of mild high pressure-based spore control technologies. The approach used in this work allowed the identification of proteins that have not yet been associated to reduced germination at moderate high-pressure. This research paves the way for further studies on the germination and superdormancy mechanisms in spores, assisting the development of mild spore inactivation strategies.

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Sterilization Processes in the Pharmaceutical Industry

Cited by 11 publications

References 23 publications

To infinity and beyond: Strategies for fabricating medicines in outer space

To infinity and beyond: Strategies for fabricating medicines in outer space

The Effect of Heat Sterilization on Key Filtration Performance Parameters of a Commercial Polymeric (PVDF) Hollow-Fiber Ultrafiltration Membrane

Moderate High-Pressure Superdormancy in Bacillus Spores: Properties of Superdormant Spores and Proteins Potentially Influencing Moderate High-Pressure Germination

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