"Optimize. Save. Sustain."
GradeZone, founded in 2023, excels in clean room solutions for pharmaceutical and related industries. With 17+ years of experience, we prioritize project design, execution, testing and validation, emphasizing energy-efficient HVAC systems and regulatory compliance, fostering industry-leading controlled environments.
1. Vital for Pharma Success: Our HVAC design is the crucial of pharma facilities. From medication like pills (OSD) to life-saving injections, we power the heart of pharmaceutical production.
2. Saving Energy, Saving Costs: HVAC systems can use a lot of energy, but we make them more efficient, which reduces energy expenses.
3. Experience Guides You: Our team of experienced engineers helps to navigate the complex world of pharmaceutical regulations, including WHO, USFDA, MHRA, PIC/S, TGA and more.
4. Making Compliance a Breeze: Global regulations can be a maze, but we're your navigation system. We simplify the rules, making sure your investments are future ready.
5. Safety First: We prioritize safety and compliance, using risk assessments to keep operations trouble free.
6. Regional GMP Experts: We understand the Good Manufacturing Practices (GMPs) relevant to your location and market.
7. Seamless Harmony: We're not just about HVAC design; we're the architects of seamless integration, making sure everything clicks in your facility.
8. Precision Matters: We meticulously oversee personnel movement, equipment positioning, layout, security measures, gowning procedures, and the optimal HVAC configuration.
1. Seamless Integration of HVAC, BMS and EMS Systems: We're experts of HVAC, BMS and EMS systems to make pharmaceutical facilities run smoothly.
2. Precision Installation Planning: We meticulously plan the installation process, adhering to strict timelines and budgets, while accommodating the complex and demanding nature of pharmaceutical technologies.
3. Interdisciplinary Installation Teams: Our interdisciplinary teams work together to install and integrate complex systems, ensuring safety, efficacy, and operational efficiency.
4. Compliance with Stringent Quality Standards: We execute installations with a focus on regulatory compliance and adherence to industry-specific quality standards, maintaining the integrity of pharmaceutical operations.
5. Resource Optimization: Efficient resource allocation during installation ensures the deployment of skilled personnel and equipment, leading to cost-effective project execution.
6. Real-time Issue Resolution: Our teams are equipped to address installation challenges promptly and effectively, minimizing delays and keeping the project on schedule.
7. Sustainability-Focused Installations: We prioritize eco-friendly practices and energy-efficient solutions during installation, reducing environmental impact and long-term operational costs.
8. Client-Centric Installation Approach: We customize our installation approach to meet the unique requirements and objectives of our clients, ensuring their satisfaction and success throughout the project.
1. Functional Validation: We conduct a thorough functional validation to ensure that all systems and equipment operate as intended, meeting the requirements of your pharmaceutical facility.
2. Performance Testing: Our team performs performance tests to validate that your systems can consistently meet the specified operational parameters and requirements. We run trials to validate performance while ensuring the operational qualification of control logic.
3. Documentation and Reporting: We create detailed documentation of the operational qualification process and provide comprehensive reports for your records and compliance.
4. Environmental Monitoring: We monitor and validate critical environmental conditions to ensure they remain within the acceptable range during operational qualification.
5. Customized SOP Management: We assist in managing customized Standard Operating Procedures (SOPs) for operations, cleaning, maintenance, and compliance.
6. Instrument Calibration and Qualification Checks: We provide a list of instruments, perform calibration verification, and conduct operational qualification checks.
8. Issue Resolution and Customized Approach: Our teams promptly address issues and provide a customized approach to meet your operational qualification needs.
1. Comprehensive HVAC Validation: We offer a comprehensive validation service for HVAC systems in pharmaceutical facilities, ensuring compliance with ISO 14644, local guidelines, and client/consultant requirements.
2. Certification, Calibration, and Documentation: We provide certificates and calibration reports while offering a complete package of documentation. This includes operation manuals, certificates, and calibration reports, essential for compliance and regulatory purposes.
3. Balancing Expertise: Our expertise extends to pressure and air balancing, preventing cross-contamination and ensuring proper airflow patterns. We also offer water balancing services for efficient water distribution.
4. Air Quality Assurance: Our services encompass airborne particulate testing to maintain stringent cleanliness standards, and airflow pattern testing with videography to assess and visualize system performance.
5. Filtration Integrity: We ensure filter integrity through filter velocity tests and filter integrity tests, preventing potential contamination and maintaining air quality.
6. Environmental Monitoring: Detailed records of temperature, humidity, and pressure are maintained to demonstrate environmental conditions within specified ranges over an extended period.
7. Training and Manuals: In addition to providing operation manuals, we arrange training sessions for operators as per your requirements, empowering your team to effectively manage and maintain the HVAC system.
8. Detailed As-Built Drawings: We prepare comprehensive HVAC as-built drawings, including duct drawings, AHU layouts, equipment layout, and more. These drawings serve as valuable references for system maintenance and expansion planning.
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