Validation and Service
14644-3: Testing Methods:
- Airflow Volume and Velocity Tests
- HEPA Filter Integrity Testing
- Airflow Visualisation Checks
- Room Recovery
- Room Pressurisation
- Particle Count Analysis (viable/non-viable)
- Temperature & Relative Humidity
- Sound & Lighting Checks
- Microbial testing
Relevant Standards
EU GMP – Good Manufacturing Practices
Authorisation and licensing Agency recommended practices and minimum requirements needed to conform to guidelines for the manufacture and sale of:
- Food and Beverages
- Cosmetics
- Pharmaceutical products
- Dietary supplements
- Medical devices
Quality, Safety, and Efficacy – To ensure products are safe, consistent, and of high quality. Ensured using a Quality Management System (QMS):
- Ensuring process is consistent
- Well documented
- Personnel – well trained
- Product checked for quality
IMS – Integrated Management System
“Right First Time” approach to our projects,
Are committed to complying with customer, legal and other requirements
Continually improving the effectiveness of the quality management system.
We recognise quality management as a means of serving the needs of all our customers and it is our policy to:
- Eliminating hazards and reduce OH&S risks.
- Consultation and participation by staff in health and safety.
- Identifying and complying with all relevant legislation.
- Compliance and adherence with all other requirements including those issued by customer, local and statutory authorities.
- Continual improvement in OH&S, environmental and quality performance.
- The prevention of injury and ill-health.
- The protection of the environment, prevention of pollution and reducing our impact on the environment.
- Compliance with the requirements of ISO 9001, ISO 14001 and ISO 45001.
Service Maintenance & Repair
- Maintenance Of All Types Environment Equipment, AHU, Air Con
- Maintenance Of Labs Equipment (Fume Hoods, Isolators, Booths and LAFs)
- Building Maintenance On All Mechanical And Electric Systems
- Trouble-Shooting And Fault-Finding
- Comprehensive System Inspection Procedure
- Detailed Maintenance Documentation
- UVC Lighting
- Filter Supply Fitting And Testing
- P.A.T. Testing
CTCB-I
CTCB Certified to Validate own cleanroom and containment projects and also 3rd party installations. DQ , IQ , OQ, FRS, URS, Validation reports etc.
HVAC Commissioning
- HVAC commissioning services (HVAC TAB)
- Surveys & Troubleshooting
- IAQ Surveys (Indoor Air Quality)
- Air and Water Systems Balancing
- Fan Performance Testing
- Fan Filter Unit
- Fan Coil Unit
- Pressure Cascading
- Detailed HVAC Commissioning Documentation
Continued Compliance
- Maintain Validation Contract with clients.
- Scheduled testing intervals agreed.
- Number and Frequency of visits determined on a risk-based approach.
- Not all testing is required on each visit.
- Performed under “at rest” conditions except where otherwise necessary to perform “in operation”, e.g., particle count testing, airflow visualization etc.
- Frequency is also factored on risk-based approach i.e., less/more testing per annum dependent on processes and client requirements.
Testing: | ≤ ISO Class 5 | > Class 5 |
Particle count | Every 6 months | Every 12 months |
HEPA filter leak testing | Every 6 months | Every 12 months |
Airflow volume / velocity | Every 12 months | Every 12 months |
Air Pressure Difference Check (gauges) | Every 12 months | Every 12 months |