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CRITICAL ENVIRONMENT SERVICES
CRITICAL HVAC DECONTAMINATION
Your HVAC is at the heart of your cleanroom. Trust our team of experts to keep your cleanroom’s heart healthy.
With increased air supply , air flow patters with the use of high efficiency filters and room pressurization. The increase air supply brings you the desired air changes per hour for your cleanrooms.
• We evaluate and provide advise, guidance and service with your critical HVAC infrastructure.
• Working with stakeholders to develop best plan of action for each project.
• Validation of the work with biological and chemical indicators.
• Testing and cycle development service is available.
• Eliminating the mold and maintaining the cleanliness.
• Vibraclean works with trusted partners to ensure the success of your project.
• Our core competency is in the execution of the work.
However we are involved in all steps and collaborate with stakeholders to ensure a positive outcome.
DECOMMISSIONING OF CRITICAL ENVIRONMENTS
Vibraclean has built a network of experienced, hands-on, trusted partners to get your project completed.
Vibraclean collaborates closely with all stakeholders:
• Regulatory Agencies
• External Consultants
• Quality Control
All environmental risks need to be mitigated and the space needs to be rendered safe prior to any demolition, renovation or property sales. Before relocating, disposing of, re-certifying laboratory equipment or property sales and when vacating a laboratory, the space and equipment must be certified to be free of contamination.
Depending upon the contaminant, be it biological, chemical, hazardous, and the contaminated surface, impervious vs porous, and structural vs nonstructural, Vibraclean will utilize the most stringent methods and procedures to dean and remediate the space.
Vibraclean decontamination services will effectively neutralize all contaminants.
Whether you need an entire room decontamination, or scientific equipment including Biosafety Cabinets, Incubators and Centrifuges, Vibraclean decontamination services will effectively neutralize all contaminants.
We plan and prepare with our clients as each job is unique with its own set of requirements.
Regardless of the size and scope of your project, we insure the safe, timely, and effective neutralization of contaminants in your facility.
- We establish SOP and protocols on how the work will unfold.
- Typically the equipment requires a documented manual 2-3 stage clean.
- Some components may need to disassembled or removed.
- We work with manufacturers representatives during this process.
- Equipment and tested and checked upon completion.
ionized Hydrogen Peroxide (iHP™) Decontamination:
iHP™ is our method of choice to get the 6 log results our clients are seeking.
Our trained technicians use iHP™ with biological and chemical indicators. Safely and with minimal impact on materials in area.
Using iHP™ decontamination method will ensure agent neutralization with minimal down time.
Equipment Decontamination list:
- Cleanroom and Laboratory Equipment:
- Biosafety Cabinets
- Fume Hood
- Water Bath
- Refrigerators & Freezers
- Balances & Scales
- Chemical Storage Cabinets
- Equipment at end of its life cycle
- …and all other laboratory equipment
Manufacturing Process Equipment:
Custom Built Equipment of any size and scale.
GMP COMPLIANT DOCUMENTATION
Good Documentation Practice (GDP) are key components of GMP compliance.
Good record-keeping not only helps you during regulatory inspections (GMP audits), it is mandatory to ensure your documentation practices — and your products — meet industry standards and legal requirements for safety, efficacy and product quality.
We provide industry complaint documentation for the work that we perform.
Our SOP documentation meets the requirements of FDA, Health Canada, PHAC, CFIA and other governing agencies.
Vibraclean collaborates with clients and shares SOP documentation to ensure if fits into your organizations templates and best practices.
Our GDP trained staff understand Record-keeping SOPs help manufacturing operations meet their quality standards and risk management standards.
Good documentation practices are also essential for attaining ISO-9001-2015 certification and other industry-specific ISO certifications specific to your industry, e.g. ISO/IEC 17025 (for laboratory testing and calibration standards); ISO/IEC 27001 (for information security management system / ISMS) and ISO 13485:2016 (for medical device manufacturing).
All work is performed under strict NDA agreements.