Validation in pharmaceutical manufacturing and research ensures processes, equipment, and systems consistently meet quality and safety standards. Validation cycles test performance under real conditions, while processes like sterilisation and bio-decontamination must comply with GMP.
Problem-solving involves identifying and correcting deviations through root cause analysis and corrective actions. These practices confirm reliability, prevent contamination, and maintain compliance, safeguarding both product quality and research integrity.
Protak Scientific produce Enzyme Indicators which can be calibrated with Biological Indicators to test bio-decontamination validation success or failure within 60 seconds. Allowing many large-scale pharmaceutical manufacturers to quickly change and test the validation process and drastically reduce downtime waiting for validation test results.
| Biological Indicators | Enzyme Indicators | |
| Time for results | > 7 days | 60 seconds |
| Data available | Binary | Quantitive values |
| Variation | -50-300% | < 15% |
| Source | Bacterial Spores | Enzymes |
Enzyme Indicators offer a range of advantages over traditional Biological Indicators. One of the major benefits is Enzyme Indicators’ ability to provide clear, quantifiable results in seconds rather than days. This means users can have full confidence in the effectiveness of their bio-decontamination validation cycles and processes, which in turn leads to improved efficiency and reduced costs for these critical activities.
Traditional Biological Indicators require a seven-day or more incubation period before they can provide a result as to whether a gaseous bio-decontamination process has failed. By contrast, Enzyme Indicators give answers in just 60 seconds, providing for reduced costs, immediate batch verification and reduced risk that products will have to be destroyed.
Because Enzyme Indicators offer detailed, quantifiable data as opposed to the binary pass/fail information Biological Indicators deliver, this allows users to create data on their activities using the Athena software. In turn, this data can be used to identify areas for bio-decontamination cycle improvement.
Enzyme Indicators can improve validation cycles, streamline bio-decontamination processes and facilitate rapid problem-solving by delivering quantitative, real-time data on microbial inactivation.
Immediate assessment of bio-decontamination efficacy enables prompt decision-making and reduces downtime. This rapid feedback is crucial for optimising bio-decontamination cycles, as it helps to identify areas where the distribution may be inadequate or where dwell times need adjustment.
The precise data obtained from Enzyme Indicators can also support root-cause analysis and corrective actions, contributing to continuous improvement and compliance in environments where sterility is critical.
How Pfizer uses Enzyme Indicators to improve bio-decontamination validation cycles and processes
Applications of Enzyme Indicators in an aseptic production environment
How EIs increased isolator productivity by >75% in ten days
Bio-decontamination results in 60 seconds
Immediate Quantifiable Results
Increased or enhanced performance assurance
Protak Scientific is the manufacturer of a rapid validation technology for gaseous bio-decontamination using Enzyme Indicators, developed in collaboration with Public Health England (now the UK Health Security Agency). One of our largest sectors is pharmaceutical manufacturing, where we partner with over 80% of the largest pharmaceutical companies.
We support multiple sectors where efficient bio-decontamination validation cycles, processes and problem-solving are critical to safety and efficacy. Our Athena™ software delivers real-time quantifiable results for cycle effectiveness, with advanced reporting capabilities and enhanced audit and review features that ensure all operations meet compliance requirements.
These services help companies design manufacturing facilities, build bespoke equipment or manage quality assurance in pharmaceutical production, providing clients with the most effective method of bio-decontamination validation for any cleanroom setting or sterile environment.
Read about the benefits of Enzyme Indicators to improve bio-decontamination validation cycles, processes and problem-solving.
Biological Indicators vs Enzyme Indicators at a glance.
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