Publicly Traded Pharmaceutical Drug Producer
Use Case: Cleanroom Testing
Our client, a publicly traded pharmaceutical drug producer, is a global leader in the research and development of pharmaceutical products. They manufacture millions of doses of tablets, aerosols, gels, injectables, and implants at their production facilities for patients and healthcare providers around the world. One of their offsite production facilities faced challenges in maintaining a controlled and contaminant-free environment as they ramped up production of a new therapeutic product.
Goal
The primary objective was to measure and monitor microbial organisms' growth and airborne contaminants' presence in production areas. Given the nature of therapeutic formulations, this required highly detailed, strict, and comprehensive monitoring of microorganisms and environmental contaminants.
Our Challenge
The facility struggled with consistently implementing and executing recommended preventative production safeguards. Maintaining a contaminant-free production environment was critical to ensuring the safety and efficacy of the products.
Our Insight
Producing therapeutic formulations necessitates rigorous and ongoing environmental monitoring to ensure compliance with Good Manufacturing Practices (GMP). Enhancing the monitoring systems and training staff was evident as crucial to achieving and maintaining the desired levels of environmental control.
Solution
Sure-BioChem Laboratories (SBL) was engaged to address these challenges. Following a thorough consultation, SBL developed a tailored environmental monitoring sampling plan specifically designed for the client's production operations. The plan focused on identifying key areas of concern and implementing targeted strategies to reduce contaminants.
Our Results
- Comprehensive Cleanroom Monitoring Plan: SBL's tailored sampling plan enabled the client to monitor their production environment more effectively.
- Reduction in Contaminants: Implementation of the sampling plan led to a consistent and significant reduction in the levels of airborne contaminants and microorganisms in the production facility.
- Direct Impact on Production Efficiency: Through the implementation of SBL's sampling plan, the facility was able to implement specific measures, such as [specific measures], that directly led to an overall increase in production efficiency.
- Enhanced Employee Understanding and Compliance: SBL's consultation and monitoring services strengthened employees' understanding of GMP. This included addressing practices that previously increased the presence of microbial agents and environmental contaminants, thereby establishing a more compliant operating environment.
Conclusion
Sure-BioChem’s expertise in cleanroom monitoring significantly improved the client’s ability to maintain a controlled and contaminant-free production environment. This collaboration enhanced production efficiency and ensured compliance with GMP standards, leading to safer and more effective pharmaceutical products for patients worldwide.
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Sure-BioChem Laboratories
1000 Atlantic Avenue
Camden, NJ 08104
1.866.708.7106