Best In the highly regulated pharmaceutical industry, maintaining controlled environments is crucial for ensuring product quality, safety, and regulatory compliance.
Tempkold provides advanced Clean Room Solutions designed to meet the specific requirements of pharmaceutical manufacturing processes. From sterile production areas to packaging and testing zones, our systems support optimal conditions for your operations, ensuring the integrity of products and compliance with industry standards.
Tempkold’s clean room systems are engineered to meet the rigorous demands of pharmaceutical production environments. With our solutions, your facility will benefit from:
Precise Environmental Control: Maintain stable temperature, humidity, and particle contamination levels to safeguard the production of medicines.
Energy Efficiency: Our clean rooms are designed with energy efficiency in mind, helping you reduce operational costs while maintaining optimal performance.
Compliance with GMP and ISO Standards: Our systems are designed to meet current Good Manufacturing Practices (GMP) and ISO 14644-1 standards, ensuring your clean room operates in full compliance with industry regulations.
Scalability and Customization: We offer scalable solutions that can be tailored to meet the specific needs of your facility, whether you’re working with small-scale batch production or large-scale manufacturing.
Advanced Filtration Systems: High-efficiency particulate air (HEPA) and ultra-low penetration air (ULPA) filters ensure the highest level of air purity and control of particulate contamination.
Temperature and Humidity Control: Maintain consistent temperature and humidity levels within strict tolerances to meet pharmaceutical manufacturing requirements.
Airflow Management: Our systems are designed to optimize airflow patterns, reducing the risk of cross-contamination and providing a sterile environment for pharmaceutical production.
Modular Design: The flexibility of our modular clean rooms allows for easy expansion, reconfiguration, or relocation to meet your evolving business needs.
Monitoring and Automation: Integrated systems for continuous environmental monitoring and automated adjustments help you maintain consistent, controlled conditions.
Minimized Downtime: With robust designs and reliable materials, Tempkold’s clean rooms ensure minimal maintenance needs and maximum uptime for your production process.
Clean Room Classifications: Designed to meet ISO 14644-1 classifications from Class 1 to Class 9, based on your specific environmental requirements.
Airflow Velocity: Optimized airflow rates from 0.3 m/s to 0.45 m/s, depending on clean room classification.
Temperature Control: Temperature regulation capabilities ranging from 18°C to 24°C to ensure consistent environmental conditions.
Humidity Control: Humidity levels can be maintained between 30% and 60% RH, ensuring a stable environment for pharmaceutical manufacturing.
Construction Materials: Clean rooms constructed using non-porous, easy-to-clean materials that comply with pharmaceutical industry standards.
Power and Control Systems: Equipped with advanced energy-efficient power and control systems that ensure precise environmental control with minimal energy consumption.
Enhanced Product Integrity: Protect your pharmaceutical products from contamination and degradation, ensuring consistent and reliable production.
Regulatory Compliance: Achieve compliance with national and international regulatory standards, ensuring your products meet the highest quality benchmarks.
Cost Efficiency: Reduce operational costs through energy-efficient systems that maintain optimal conditions without excessive energy use.
Risk Mitigation: Minimize risks associated with contamination and non-compliance through proactive design and continuous monitoring of critical environmental factors.
At Tempkold, we take a holistic approach to delivering clean room solutions tailored to your pharmaceutical manufacturing needs. Our process includes:
Consultation and Design: We work closely with you to understand your needs and design a clean room solution that aligns with your operational goals.
Installation and Commissioning: Our team handles the installation and commissioning of the clean room, ensuring smooth setup and integration with your existing operations.
Ongoing Support: We provide ongoing maintenance and support to ensure your clean room continues to operate at peak performance.
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