Sterility Testing Research Articles

Implementation and microbiological stability of dose-banded ganciclovir infusion bags prepared in series by a robotic system

ObjectivesThe implementation of dose-banding (DB) in centralised, pharmacy-based cytotoxic drug preparation units allows the preparation of standardised doses in series. The aim of this study was to evaluate the feasibility...

Sterility Testing for Cellular Therapies: What Is the Role of the Clinical Microbiology Laboratory?

Sterility testing of cellular therapy products along with the associated environmental monitoring requirements for aseptic facilities, including compounding pharmacies, continues to impact clinical microbiology laboratories, as evidenced by the numerous discussions recurring on American Society for Microbiology Division C and ClinMicroNet listservs. This minireview provides an overview of this complex field of current good manufacturing practices (cGMP) based on biopharmaceutical industry standards and summarizes the compendial and alternative rapid microbial test methods available for product sterility and Mycoplasma testing. In addition, this minireview highlights major overarching regulatory requirements governing any laboratory performing product testing as regulated by the United States Food and Drug Administration (FDA). These requirements are different from the more familiar clinical requirements of the Clinical Laboratory Improvement Act of 1988 (CLIA '88), the College of American Pathologists (CAP), and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), all of which have no jurisdiction in this area. As the cellular therapy field continues to advance and an increasing number of medical centers participate in clinical trials of these novel therapies, it is critical that laboratories have a sound understanding of the major regulations and cGMP practices governing microbiological testing in the biopharmaceutical industry.

Ophthalmic pH Triggered in situ Gelling System of Tobramycin: Formulation and Optimization using Factorial Design

Objectives: The objective of present study was to formulate and optimize ophthalmic pH triggered in situ gelling system of tobramycin in order to enhance residence time and provide prolonged drug release. Methods: Two factor three level full factorial design was applied to study the effect of concentration of carbopol 980 and HPMC K4M on dependent parameters such as viscosity, gel strength and gelling capacity. Overlay plot method was used to optimize the formulation. The optimized formula was evaluated for clarity, pH, viscosity, gel strength, gelling capacity, in vitro drug diffusion, sterility test, ocular irritancy test, Isotonicity test, antimicrobial efficacy and stability studies. Results and Discussion: The results showed that increasing the concentration of carbopol980 and HPMC K4M, there was increased in the gelling capacity, its gelling strength and viscosity. All the formulations had pH around 5. The optimized formulation prolonged the drug release for eight hours which had a composition of 0.48% carbopol980 and 0.52% HPMC K4M. From the kinetic modelling it showed that it followed Higuchi model for drug diffusion. The gel formed in vitro produced sustained drug release up to 8 hr. Results showed no significant change in the results of appearance, pH, viscosity, gelling capacity and drug content when stored at accelerated condition and room temperature for a period of one month. Conclusion: Optimized formulation was sterile, non-irritant, isotonic and stable and also it can be substitute to conventional eye drops formulations of tobramycin which could provide a sustained release for a period of eight hours.

Assessing the Validity of the Storage of Sterilized Surgical Instruments Steam under Pressure

The chronological order of validity of sterile material is indicative adopted by hospitals for the use of hospital instruments after sterilization, intending to maintain sterility and to ensure the environmental conditions of storage, handling, and transportation. This study aimed to evaluate the sterility validity of surgical instruments stored in the sterilization center regarding the feasibility of their safe use over time. Fifteen surgical forceps were sterilized in aseptic (surgical grade) paper and polypropylene blankets packaging and stored in the arsenal of a large hospital. The materials were tested monthly in a laminar flow cabinet to test how long the surgical instruments remained sterile. Sterility tests showed no gram-positive or gram-negative bacterial or fungal microbiological growth from any of the samples evaluated according to storage time (30, 60, 90, and 120 days). Sterile instruments can be safely used for up to 120 days, thus saving costs by avoiding the repacking of those items.

Radiation Dose Audit Failures: Truth and Consequences.

The validation of a radiation sterilization dose involves an initial sterilization dose determination as well as maintenance of that sterilization dose. The procedures for maintenance of the sterilization dose typically include the periodic use of two types of tests: bioburden and dose audits. The details for the procedures are outlined in the ISO radiation sterilization standards. These documents also provide guidelines for recommended actions in response to the results of the two tests. The results for the dose audit are based on the number of positive tests of sterility (TOS) for products that have been irradiated at a verification or experimental dose. When the dose audit yields TOS positives, it is often thought that they indicate a sterilization failure and nonsterile product. The belief that any TOS positive is a failure is an incorrect assumption because of the statistical basis used for the determination of the sterilization dose. This article will outline the truth of what dose audit TOS positives mean in terms of the sterility assurance of product, as well as the consequences of TOS positives.

4324 Phase 1 Sterile Product Formulation and Manufacturing at Academic Medical Centers: An Introduction for Translational Researchers

OBJECTIVES/GOALS: To facilitate the development of innovative injection products by providing translational researchers with a regulatory and manufacturing road map for producing small batch sterile products for Phase 1 research use. To leverage recent AMC investments in facility improvements and pharmacy training in the areas of sterile product production, testing, and environmental controls, that can be used to support production of phase 1 clinical trial supplies METHODS/STUDY POPULATION: Searching and organizing relevant data and information from web portals and databases in the following: areas: FDA, EMA, USP regulations, regulatory science, pharmaceutical formulation and analytics, supply vendors, analytical testing laboratories, and product testing laboratories. Present the information using a user friendly format including flow charts and development timelines, taking the perspective of the translational investigator. RESULTS/ANTICIPATED RESULTS: Choosing AMC resources vs outside consultants and vendors, leveraging local resources where possibleQualifying and monitoring suppliers, testing laboratories, in-house departments, and Contract Drug Manufacturing Organizations (CDMO)Bringing together the deliverables for the IND CMC sectionWhere and how to leverage available products and science to simplify safe and reliable productionDISCUSSION/SIGNIFICANCE OF IMPACT: Use and utility of injectable drug products, both small molecule and biologics, is growing rapidly, and is projected to continue to escalate well into the next decade. This is due not only to advances in medicine, but also to improvements in AMC-based sterile product production, and a better understanding of small batch manufacturing methods. All three trends align in academic medical centers (AMC) and can be utilized by translational researchers, if they can understand the potential and regulatory requirements.

Removal of bacterial growth inhibition of anticancer drugs by using complexation materials

AbstractIn the context of batch production of cytotoxic drugs in hospital pharmacies with the need of sterility testing, the objective was to validate the use of Rapid Microbiological Method (RMM), and to develop adequate neutralization method in case of inhibition of bacterial growth. The potential microbiological growth inhibitory effect of three anticancer drugs (5 fluorouracil, irinotecan and oxaliplatin) selected for batch production was assessed on BacT/ALERT® system. Among cytotoxic drugs, only 5FU exhibited inhibitory effect on microbiological growth using rapid microbiological method. To counteract this effect our purpose was to use neutralizing agents complexing the drug i. e. activated carbon or ion exchange resins. The microbiological bactericidal concentration of 5FU was very low (1.10–4 mg/mL) indicating the absolute need to neutralize the whole drug before sterility test. The complexation was validated by High Performance Liquid Chromatography control of the residual 5FU concentration in solution after the use of neutralizing agents. Only activated carbon was able to fully capture 5FU when previously diluted at 5 mg/mL. Conversely, the resins, in the condition of the study, were not able to fully capture 5FU whatever the dilution. The microbiological growth on BacT/ALERT® system after active carbon treatment was successfully confirmed with Staphylococcus aureus. Based on this validation results a method was then developed to routinely be able to perform sterility test of the batches produced and was confirmed on five microbiological species (i. e. S. aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans, Aspergillus brasiliensis). Our work gives a new insight for considering sterility testing by rapid microbiological method even for drugs exhibiting inhibitory effect on microbiological growth.

Microbiological stability tests with simulated broth preparations and integrity testing for sterile standard cytotoxic preparations

AbstractObjectivesThe objectives were to assess the microbiological stability and the physical enclosure integrity of the overwrapping for batch production of standard cytotoxic injectable solutions.MethodsBroth culture media were used in place of cytotoxic drugs to assess the worst case in term of microbiological contamination risk. Iterative sterility tests on batches were performed for 60 days using rapid microbiological method. Validation of microbiological growth of culture media was assessed by direct inoculation of <100 CFU/mL of six microbiological strains recommended by European Pharmacopeia. Validation of the ability of growth of microorganisms in 11 cytotoxic solutions and one monoclonal antibody was assessed using eight strains. In addition, the physical integrity of the seal of the overwrapping containing cytotoxic preparations was assessed by dynamometric method and dye penetration test.ResultsNo microbiological contamination was observed on all units of batches for 60 days of investigation. The ability to detect microbiological growth in cytotoxic solutions was validated for the eight challenge microorganisms after 1/10 dilution for cytotoxic investigated, except for 5 Fluorouracil, gemcitabine and cisplatin. In addition, physical integrity testing of the seal of overwrapping pointed out the need of specific validation of heatsealer and operator education.ConclusionsBesides physico-chemical testing, microbiological stability testing combined to physical integrity testing is the additional part of the development method for batch production of sterile drugs in hospital.

Formulation and Evaluation of Protein Bound Paclitaxel Nanoparticles for Injectable Suspension

Aims: The aim of present study is to develop Paclitaxel nanoparticles for injectable suspension, an anti-neoplastic drug formulation.
 Study design: Mention the design of the study here.
 Place and Duration of Study: Sagar Institute of Research & Technology- Pharmacy, Ayodhya Bypass Road, Bhopal, between June 2017 and June2018.
 Methodology: The Human serum albumin (HSA) is the most abundant plasma protein in the human blood with a half-life of 19 days. It can reversibly bind hydrophobic drug substances, transport them in the body and release drugs at cell surface. The formulation is prepared by homogenization at high-pressure of paclitaxel in the presence of human serum albumin into a nanoparticle colloidal suspension. Paclitaxel nano particles have been stabilized by human albumin and maintain the average size of 100 nm
 Results: The particle size of the reconstituted solution is checked using the laser diffraction Technique the particle is White to yellow lyophilized after reconstitution the particle become homogeneous milky suspension without visible particulates. Reconstitution time NMT 25 minutes 20.45 sec. The assay was performed by HPLC and found to be 90.0% to 110.0% of label. The retention time of Paclitaxel peak obtained in sample corresponds to the respective standards obtained from standards the pH NLT 6.00 to NMT 8.00 Particle size NLT 100 nm – NMT 200 nm. Sterility test was comply as per USP <71>
 Conclusion: The nano-delivery systems could have the potential to be free of Cremophor EL and ethanol, enhance Paclitaxel solubility, improve Paclitaxel pharmacokinetic profiles in vivo, decrease its side effects, passively or actively target to tumor sites due to the EPR (Enhanced Permeability and Retention) effect and the use of targeting ligands, respectively, nanotechnology is a very active research area in both academic and industrial settings.
 Keywords: paclitaxel, Anti-cancer, nanotechnology, Injectable, Suspension

Molecular characterization of dengue and chikungunya viruses and their association with the liver profile

The episode of acute febrile illnesses increases day by day due to poor socioeconomic status in developing nations. Dengue and Chikungunya are emerged as important arboviral and alpha virus diseases respectively, with significant impact on disease burden residing these areas. Both viruses, seems to have hepato-toxic effect. Affiliation of liver in form of derangement in liver function tests is common. Present study focuses on the hepatic manifestations of the liver injury in dengue and chikungunya patients. A cross-sectional study was conducted on patients attending Out-patients and In-patients Department of Medicine at Shri Mahant Indiresh Hospital Dehradun. 161 cases were included in the study. 5 ml of blood sample from each of them is collected in a sterile test tube. The blood samples were analyzed via RT-PCR technique at Central Molecular Research Lab in Biochemistry Department of Shri Guru Ram Rai Institute Of Medical and Health Sciences Dehradun and Liver profile was analyzed at SMI Hospital. Liver enzymes were found to be raised in male as well as in females for both dengue and chikungunya. But dengue was found to be more hepato-toxic when compared to chikungunya with statistical significance value (<0.0001).

КОЛИЧЕСТВЕННАЯ ОЦЕНКА УРОВНЯ МИНЕРАЛИЗУЮЩЕГО ПОТЕНЦИАЛА РОТОВОЙ ЖИДКОСТИ У ДЕТЕЙ

Subject. Oral fluid plays a crucial role in maintaining the physiological balance of the processes of remineralization and demineralization in tooth enamel, especially in childhood. The mineralization and demineralization of tooth enamel depend on the mineralizing potential of the oral fluid, which is associated with the concentration of calcium ions and phosphate ions in the oral fluid at a certain pH of the medium. Today, the description of the morphology of crystals is reduced mainly to a qualitative assessment. This is inconvenient due to subjectivity in data processing.
 The goal is to increase the accuracy and objectivity of diagnosing the level of mineralizing potential of the oral fluid by quantifying the type of saliva microcrystallization and expand the ability to diagnose the risk of developing and exacerbating the degree of activity of the carious process in a pediatric dentistry clinic.
 Methodology. The research material was human saliva, which was taken in the morning, on an empty stomach, before brushing your teeth in a sterile test tube with a tight-fitting lid.
 Results. The results of the studies revealed statistically significant differences in the periodicity parameters with respect to type III saliva microcrystallization (p <0.001), in which the mineralizing potential of the oral fluid is less favorable for the optimal level of ion exchange between the oral fluid and the tooth enamel surface during the maturation period of the child’s dental hard tissues. Suggested technique determining a periodicity parameter characterizing the quantitative difference in the types of saliva microcrystallization can be used To assess the level of mineralizing potential oral fluid.
 Conclusions. The study allows to increase the accuracy and objectivity of diagnosing the level of mineralizing potential of the oral fluid by quantifying the type of microcrystallization of saliva and expands the possibility of diagnosing the risk of developing and exacerbating the degree of activity of the carious process in the clinic of pediatric dentistry.

A modern compendial automated and rapid sterility testing technology for cell and gene therapy products

Background & Aim Cell and Gene Therapies are currently being developed to treat different diseases. By design, those therapies have very short shelf lives compared to traditional sterile pharmaceutical drugs. Besides, Cell and Gene Therapies can not be sterilized by filtration, therefore the historical compendial sterility test methods that takes 14 days to complete as defined in USP : “Sterility Tests” is not compatible. In order to assess the sterility of these therapies prior to transfusion, the BacT/ALERT Dual-T, an automated and more rapid technology, has been developed to reduce the time to result while keeping the highest level of perfomance and compliance. This method has now been recognized as compendial and can be used in lieu of the traditional 14 day sterility test to assess the sterility of cell-based products as defined in the EP Chapter 2.6.27 Microbiological Examination Of Cell-Based Preparations. The objective of this work is to present the pathway to making an alternative test compendial for the specific cellular products. Methods, Results & Conclusion Method: The BacT/ALERT Dual-T will be presented and discussed as a compendial test replacing the traditional culture-based 14 day incubation sterility test, and other alternative technologies will also be discussed in comparison to compendial testing. A review of all major litteratrue and scientific articles will be presented that demonstrates the use and applicability of the BacT/ALERT Dual-T to assess the sterility of cell-based products. Different real-cases of implementation of the BacT/ALERT Dual-T within the Cell and Gene Therapies field and the biotechnology industry will be discussed, with recently adopted implementation strategies for different type therapies. And finally a regulatory update will be given, specifically on the recent advancements in several regulations and Pharmacopoeia Chapters, encouraging the use of more Modern, Rapid and Automated Sterility Testing solutions. Conclusion: Several validation studies have provided data comparing the BacT/Alert System to the compendial sterility test method and enabled the adoption of this technology as a compendial method for sterility testing of cell-based therapies. This enables the industry to replace the historical 14 day incubation historical compenidal sterility test by a much more modern and rapid automated method, which results in greater patient safety by providing final sterility results in less than 14 days.

A new application of deep eutectic solvent (DES) in fish preservation

Technology in fish preservation had gone through various scope in food industry. Application of new green chemistry of deep eutectic solvent (DES) as preservative capable to help in the prevention of fish contamination by pathogenic bacteria. The aims of this study were including the synthesis of DES, the evaluation of antibacterial activity and sterility testing of the DES using fish samples. The synthesis of choline chloride-based DES was prepared by mixing with acetic acid and oxalic acid respectively. Further testing was done using disc diffusion method for the analysis of the solvent’s antibacterial activity towards E. coli, S. aureus, B. subtilis, S. Typhi and K. pneumonia. The sterility evaluation on the preservative solvent was carried out using fish samples in different temperature and time of storage. Results analysis showed potential of the DES in antibacterial activity even at low concentration of mixture. Sterility test showed promising result by maintaining pH of the solvent at 6-7. Reduction of bacteria concentration was found in the bacterial-spiked fish samples when preserved in the DES mixture. Thus, the study proved the potential of DES as a good preservative for fish compared with the controls from single component of choline chloride, acetic acid and oxalic acid respectively..

Evaluation the Serum Level of Melatonin in Iraqi Patients with Polycystic Ovarian Syndrome

Background: Polycystic Ovarian Syndrome(PCOS) is one of the most frequent gynecological endocrinopathy that occur in premenopausalfemales, with a predominance range from 6%to10% among women of reproductive age.Melatonin (N-acetyl-5-methoxytryptamine), an neurohormone synthesized from the aromatic amino acid tryptophan mainly by the pineal gland of humans.The important of melatonin in human reproduction is still unidentified. A numerous study suggests that melatonin and reproductive hormones are closely related. This concept is based on observation of influence melatonin on sex steroid production at different stages of ovarian follicular maturation as melatonin receptors have been demonstrated at multiple sites in ovary and in intrafollicular fluid. Aim :The study aim to evaluate the role of melatonin in women with polycystic ovarian syndrome. Materials and Methods:A prospective cross-sectional study was designed taking 60 PCOS patients and 30 controls women whose ages were between 15-35 years old, from beginning of January 2019 to ending of April 2019. These patients admitted to obstetrics and gynecology unit at Babylon teaching hospital. And Five ml of blood sample was taken on day 2 of menstrual cycle by vein puncture from each subject enrolled in this study .Blood samples were collected between 07:00am – 08:00 am, and placed into sterile test tubes to serum melatonin estimation.Result: The study showed that there is the significant difference betweenPCOS women and the control group concerning melatonin level,and the highest mean of melatonin was occurred in PCOS women (61.21±13.78vs. 28.61±6.73). And also This study showed that there were the higher means of melatonin in PCOS women with positive family history than PCOS women with negative family history (66.56±11.25vs. 59.26±14.21) with significant relation.Conclusions: Women with PCOS have significant increase of serum melatonin in PCOS women. And also thisstudy could open the way for therapeutic role of melatonin in treatment of PCOS women.

Design and validation of a device for the mechanical stimulation of bioengineered 3D neo-tissue constructs

A mechanical stimulation device for cell-seeded scaffolds was designed and manufactured to provide control of dynamic compressive loading on biomimetic 3D neo-tissue constructs for enhanced tissue regeneration. Despite emerging evidence implicating the importance of mechanical forces in directing cellular differentiation and dental tissue formation, the role of variable mechanical stimuli in developing dental tissue has not been fully investigated. The device described here was designed to be easily cleanable by technicians and scientists between individual tests providing repeatable displacement of gels for their experiments. Increased extracellular matrix production of temporomandibular joints (TMJ – the joints that connect the jawbone to the skull) was observed while under loading by the device and the device is capable of providing compression as low as 0.01 mm of the desired displacement. Force calibration and sterilization testing were also performed to validate the functional requirements and device performance. The preliminary results show that the resulting device can deliver up to 2 kPa of dynamic compressive pressure to bioengineer cell-based constructs, and that ethanol sterilization is sufficient to maintain a sterile environment in long term tissue culture. In this paper, we introduce a device to mechanically stimulate bioengineered tissue formation, which could be used for a variety of applications in regenerative medicine.

Horseshoe Crab Aquaculture as a Sustainable Endotoxin Testing Source

Horseshoe crab (HSC) hemolymph is the source of Limulus amebocyte lysate (LAL), a critical component in sterility testing that ensures drug and medical device safety for millions of patients every year. Wild HSC populations have been declining as a result of use as whelk and eel bait, and largely due to capture and bleeding for hemolymph, primarily while spawning, thus posing significant biomedical supply and species viability risks. We investigated aquaculture as an alternative to current practices as a means to foster conservation by establishing a sustainable endotoxin testing resource. We found HSC aquaculture to be practicable based on routine hemolymph harvesting, batch uniformity, and LAL quality, while safeguarding animal wellbeing. Achieving sustainable LAL production could satisfy industry needs for several years with a fraction of one year’s current capture with low-impact, year-round harvesting of a finite cohort. Sustainable supplies of LAL could also be adapted to address daunting trends in septicemia and antimicrobial resistance. LAL is uniquely sensitive and specific for gram-negative bacteria, which represent 70-80% of pathogens typically attributed to sepsis. Early diagnosis of bacterial infection and timely antibiotic therapy can reduce patient mortality. However, erratic results associated with interfering substances plagued efforts to adapt LAL for clinical use in the past. Our efforts to develop new methods have yielded a promising LAL screening technique to detect a gram-negative bacteria and endotoxins in human blood.

Comparison of quality control methods for drugs against animal E. coliinfection in the State and European Pharmacopoeias

E. coli infection is an acute infectious disease of all young farm animals which causes diarrhea. It is caused by pathogenic Escherichia coli and entails great damage to livestock. At the present stage there are about 30 remedies to prevent E. coli infection in animals circulating in the Russian Federation. Vaccine is an immunobiological that activates acquired immunity. Vaccination is one of the safest, most effective and affordable remedies for specific prophylaxis despite a great number of therapeutic (pharmacological) drugs. All immunobiologicals in Russia must be registered, certified and their circulation must be under control. Drugs must undergo rigorous quality control. The main regulatory document, collection of standards and regulations that determine the quality indicators of substances produced in the Russian Federation and drugs made from them is the State Pharmacopoeia. This article describes how to perform sterility test of various drugs that, in accordance with the regulations, must be sterile.

Antibacterial Potential of Ethanolic and Aqueous Extracts of Carica papaya Leaves

Background: The search for newer sources of antibiotics is a global challenge pre-occupying research institutions, pharmaceutical companies and academia, since many infectious agents are becoming resistant to synthetic drugs.
 Aim: This present study sought to investigate the antibacterial potential of ethanolic and aqueous extracts of Carica papaya leaves.
 Materials and Methods: Fresh and healthy leaves of C. papaya were harvested, air dried and milled into powder. The powder was extracted using ethanol and water as solvents. The antibacterial activities of both extracts were determined by diffusion method. Nutrient agar medium was prepared using standard method. Pure cultures of Coliform bacillus, Staphylococcus epidermidis, Streptococcus viridans, Salmonella typhi and Escherichia coli were obtained from the Department of Veterinary Microbiology and Parasitology, Federal University of Agriculture, Abeokuta, Nigeria. The extracts were serially diluted to obtain 1.0%, 0.5%, 0.25% and 0.125% solutions in sterile test tubes. Sterilized 9 mm filter paper disc soaked in the diluted extracts were placed on the plate and incubated for 24 hours at room temperature. The plates were examined for clear zones of inhibition. Presence of zones of inhibition indicated activity.
 Results: the results showed that both ethanolic and aqueous extracts of C. papaya leaves exhibit antibacterial activities against C. bacillus, S. epidemidis, S. viridans and E. coli and also inhibited their growth. The effect of the ethanolic extract was greater than that of the aqueous extract. However, this activity was not observed with S. typhi.
 Conclusion: The result of the present study showed that C. papaya leaves might effectively inhibit the growth of C. bacillus, S. epidemidis, S. viridans and E. coli but not that of S. typhi. However, the ethanolic extract is more potent than the aqueous extract.

Utilization of Poloxamer as Well as Combinations with Other Polymers as Base in Ophthalmic in Situ Gel Dosage Form

The aim of this review was to find out which formulation were good for making in-situ gels using a combination of poloxamer and other bases. Formulation was characterized for appearance and homogeneity, pH and gelation studies, viscosity measurements, in vitro drug release, drug content, and stability studies. In vivo rabbit, eye irritation tests were conducted to evaluate the irritation of the in-situ gel delivery system; in addition, osmolality testing, sterility test, and isotonicity evaluation were also carried out. The results have shown that in-situ gel solution can increase residence time and also maintain the mechanism of drug release.

Risk of false compliance/non-compliance decisions for sterility test due to false-negative and false-positive test results

The sterility conditions of pharmaceutical products should consider the manufacturing conditions and the result obtained from a sterility test. The statistical and analytical limitations of the sterility test may lead to false-negative or false-positive results. Experimental determination of the probability of false-negative and false-positive results requires a very large number of assays, which may be impracticable. Thus, the aim of this work was to estimate the risk of false decisions related to sterility test due to the false-negative or false-positive test results, using a theoretical approach. The probability of false-negative results was estimated by considering the expected level of contamination in the sample, the tested volume for each item, the total volume of each item, and the number of tested items. The probability of false-positive results due to environmental contamination was estimated by considering the microbial load per plate, the sampled air volume, the total volume of the safety cabinet, the number of air changes per hour, and the volume of the test tube used in the sterility test. A MS-Excel spreadsheet provided in supplementary material can be used to estimate the probability of false-negative or false-positive test results. The probabilities of false-negative and false-positive results considering the experimental conditions were found to be 0.0045% and 0.070%, respectively. The probabilities of false-negative or false-positive test results may be combined with previous knowledge about the probability of a non-sterile lot (Sterility Assurance Level – SAL) using the Bayesian approach. The Bayesian approach allows the risk of false compliance/non-compliance decisions to be estimated. Risks to consumer and producer are significantly affected by prior knowledge of the sterility assurance level.