Client
PharmaLine
Industry
Pharmaceutical Manufacturing
Challenge
Contamination Control in Pharmaceutical Production
Background
PharmaLine, a leading pharmaceutical manufacturing company, faced consistent challenges in maintaining a contamination-free environment within its production facilities. The pharmaceutical industry demands stringent hygiene standards to ensure product integrity and safety, particularly in areas that involve sensitive products such as tablets, syrups, and vaccines. Despite their best efforts with manual sanitation methods, cross-contamination incidents remained a concern, leading to delays in production and increased risk of product recalls.
PharmaLine’s production areas required a high level of hygiene and controlled air quality to prevent contamination from external factors such as personnel entry and movement. The company needed an automated solution to maintain stringent hygiene levels, improve operational efficiency, and enhance employee safety.
Challenges
Contamination Risks
Employees entering production areas without proper hygiene measures posed significant contamination risks. Shoes, clothing, and even personal protective equipment (PPE) could carry outside contaminants into sterile zones.
Ineffective Hygiene Practices
Manual cleaning methods were labor-intensive and often failed to guarantee complete decontamination. Traditional hygiene stations lacked the efficiency to handle the high volume of personnel entering and exiting the facility.
Compliance Concerns
PharmaLine had to comply with stringent regulatory standards (e.g., GMP) that demanded a zero-tolerance approach to contamination. Cross-contamination events during audits threatened the company’s reputation and compliance status.
Operational Downtime
Traditional cleaning protocols slowed down employee movement, which led to longer transition times between shifts and increased operational downtime.
Solution
PharmaLine partnered with Nexgen to implement Nexgen’s Air Showers, a state-of-the-art automated hygiene system designed to eliminate cross-contamination risks in high-risk environments such as pharmaceutical manufacturing.
The Air Showers offer an advanced solution by using high-velocity air jets to blow off contaminants from personnel and their clothing before entering controlled areas. The system is designed to ensure the highest standards of hygiene and operates with minimal human intervention.
Key Features:
High-Velocity Air Jets
The Air Shower uses powerful, controlled air jets to remove particles, dirt, and microorganisms from personnel’s clothes, shoes, and PPE, ensuring no contaminants are carried into production zones.
Automated Operation
The system automatically activates as individuals step inside, eliminating the need for manual operation and reducing human error.
Touchless Design
A touch-free system ensures that the Air Shower remains hygienic and minimizes the risk of additional contamination caused by human contact.
HEPA Filtration with Two-Level Air Recirculation
The Air Shower is equipped with a pre-filter and a 0.3-micron HEPA filter, providing two levels of air filtration. Air is recirculated through these filters, capturing fine airborne contaminants and ensuring that only clean, sterile air circulates inside the shower.
Continuous Monitoring
The Air Shower system includes sensors that track each employee’s entry and exit, generating real-time data on hygiene compliance, which can be used for auditing and improving hygiene practices.
Implementation
The installation of Nexgen’s Air Showers was carried out in four phases:
- Phase 1 : Site Assessment : Nexgen conducted a detailed site survey of PharmaLine’s facility to assess entry points, high-traffic zones, and potential contamination risks. This helped in strategically placing the Air Showers for maximum effectiveness.
- Phase 2 : Installation and Calibration : The Air Showers were installed at all critical entry points of PharmaLine’s production areas. The system was calibrated to meet the facility’s specific requirements, ensuring thorough decontamination of personnel entering high-sensitivity areas.
- Phase 3 : Employee Training : PharmaLine’s workforce was trained on the proper usage of the Air Showers, including how to enter and exit the units and the importance of maintaining hygiene standards. The training emphasized the automated nature of the system and how it could reduce their workload while improving safety.
- Phase 4 : Ongoing Support and Maintenance : Nexgen’s team provided continuous support and scheduled maintenance to ensure optimal performance of the Air Showers, ensuring that the systems operated efficiently without any disruption to PharmaLine’s operations.
Results
Zero Cross-Contamination Events
After installing Nexgen’s Air Showers, PharmaLine achieved a zero cross-contamination rate across its entire production facility, which previously averaged several incidents per month.
Improved Compliance
PharmaLine successfully passed all subsequent audits, with auditors noting the exceptional hygiene standards and the company’s proactive approach to contamination control.
Faster Entry Times
The automated Air Showers reduced the time employees spent at hygiene checkpoints. Entry times were reduced by over 50%, improving overall operational efficiency.
Employee Satisfaction
Employees expressed increased confidence in the safety and cleanliness of their work environment. The automation of the hygiene process meant less manual labor and greater consistency in contamination control.
Reduced Downtime
The reduction in hygiene-related delays contributed to a 15% increase in operational uptime, directly boosting production capacity.
Client Testimonial
“Since installing Nexgen’s Air Showers, we’ve not only achieved zero contamination incidents but have also streamlined our processes significantly. The system is efficient, and our team feels much more secure knowing that hygiene standards are consistently maintained without any extra effort from us. It’s a game-changer for our facility!”
– Hygiene and Safety Manager, PharmaLine
Conclusion
Nexgen’s Air Showers provided PharmaLine with an effective, automated solution to meet the pharmaceutical industry’s strict contamination control requirements. By implementing this system, PharmaLine was able to eliminate cross-contamination risks, improve compliance, and enhance operational efficiency. This case study demonstrates the significant impact of advanced hygiene systems on pharmaceutical manufacturing processes.
If your facility is facing similar challenges, Contact Nexgen today to explore how we can help streamline your contamination control processes and improve safety across your production zones.