Equipment Qualification & Validation Services
Ellab not only manufactures some of the best temperature mapping equipment available; we also offer validation services specializing in temperature mapping. Our team of in-house expertly trained, validation engineers provide on-site validation and qualification services globally, with the best customer service in the industry. Our engineers are experts in temperature mapping and are available as a package with pre-calibrated Ellab equipment, ready to hit the ground running. We can help you meet complex requirements in regulated environments with significantly reduced test equipment risk.
At Ellab, we understand that our client’s needs are unique, and those needs will vary based on the evolving industry requirements for equipment qualification and process validation. Our expertise is specialized in life sciences, which includes the pharmaceutical, medical device and biotechnology industries. Additionally, we offer testing and qualification services in the biorepository/blood banking, cosmeceutical, nutraceutical, food, beverage and hospital industries.
Guidelines and Standards that Ellab Qualification and Validation Services Follow
Our validation services meet industry requirements and guidelines established by government agencies (FDA, EU/EMA/EMEA, PMDA, TGA), industry organizations (WHO, ISO, ICH, ASTM, PDA, ISPE, CAP, USP), and industry guidelines (cGMP, cGLP, cGxP, cGDP, GAMP 5, 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211). Our equipment and software systems are validated and 21 CFR Part 11 compliant. Our ValSuite software has been audited for data integrity by third party companies.
Qualification and Validation Service Reports, Protocols and SOPs
Our team of expert validation engineers have a focus on the quality and accuracy of all documentation provided to you for your project. Clients have the option to provide us with report, protocol and SOP templates or have Ellab draft documentation designed specifically for the project.
Qualification Protocol Test Case Examples
- Power Off tests
- Door Open tests
- Temperature Distribution tests
- Temperature Penetration tests
- Alarm testing
- Loaded and Empty Mappings
- Power Failure tests
- Instrument/equipment calibration
- And several more…
We understand how critical it is that all documentation meets current Good Documentation Practices (cGDP). For example, summary reports for performance qualification (PQ) are generally submitted to the FDA during facility licensing. Our validation experts know what is expected and how to accurately generate reports. We always provide both hard and soft copies of the following:
- Final summary report
- Temperature mapping data
- Test equipment calibration certificates (DANAK accredited calibration upon request)
- Pre/Post sensor calibration data
- Employee training records
- Audit trails generated by our ValSuite validation and calibration software
- IQ/OQ/PQ/CQ/RQ Protocols
- Standard Operating Procedures (SOPs)
Industries that utilize Ellab’s Validation & Equipment Qualification Services
Ellab realizes that depending on the industry, level of regulatory compliance and location has an effect on the necessary level of documentation and testing.
List of industries served for qualification and validation services:
- Life Sciences
Pharmaceutical, Biotechnology, Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), Contract Development and Manufacturing Organizations (CDMOs), Compounding Pharmacy, Nutraceuticals, Medical Device, Biorepositories & Blood Banks
For safety purposes, chemical manufacturers need to ensure that their products are being stored in the correct temperature conditions. Temperature mapping and sometimes humidity mapping therefore take place in areas such as storage rooms and warehouses to ensure uniformity and product stability.
Cosmetic manufacturers are required to qualify their stability chambers, which includes mapping in order to meet ICH guidelines, ensuring the generation of correct shelf life information. In addition, storage rooms and warehouses are also mapped for temperature and humidity to protect products and samples by keeping them in the desired environment.
- Food and Beverage
Food and beverage companies often map their processes to ensure that the products reach the necessary temperatures for consumer safety, all while maintaining product quality. Process ovens, hydrostats, cooker coolers, retorts sterilization, smoke houses, pasteurization tunnels, warehouses and cold storages are often mapped as part of this effort.
The level of qualifications that hospitals are required to meet vary significantly depending on where in the world they are located. Some require full qualification of all steam sterilization processes, including temperature mapping, biological indicator challenges and steam quality testing, while other areas in the world have bare minimum requirements for the routine process verification using biological challenges only. Other units, such as ovens, washer disinfectors, cold storages and warehouses, are also sometimes mapped in hospital settings.
Types of Equipment Qualifications and Process Validations Ellab Commonly Performs
Ellab validates and qualifies a large range of equipment and processes. Please contact Ellab for further information if the required process is not mentioned in the list below.
- Environmental Chamber Qualification / Validation Services
Liquid Nitrogen (LN2) Freezers, Mechanical Freezers (-150°C, -90°C to -60°C, -40°C, -20°C), Refrigerators (2°C to 8°C), Incubators (Temperature, Humidity, CO2), Stability chambers (Temperature, Humidity, Photostability), ICH Chambers, Temperature Controlled Trucks and Trailers.
- Environmental Room Qualification / Validation Services
Stability storage rooms, Walk-In Cold Rooms, Walk-In Freezers.
- Warehouse Mapping / Qualification / Validation Services
Meeting a variety of requirements that often include summer and winter temperature mapping of warehouses, and in some cases spring and fall. Seasonal mapping is required if meeting cGMP and / or USP 1079 Good storage and Distribution practices for drug products is needed. Calculation of Mean Kinetic Temperature (MKT) is easy with Ellab’s validated software.
- Sterilizer Qualification and Sterilizer Validation Services
Autoclave Qualification, including Cycle development, Load mapping studies, Temperature penetration studies, Biological Indicator testing, Fixed-load and variable-load approaches, Gravity and Vacuum autoclave types cGMP, cGLP, ISO 17665, EN 285 criteria.
- Depyrogenation Oven & Tunnel Qualification Services
Cycle Development, Load temperature mapping, Endotoxin challenge testing and Fixed load and variable load approaches.
- Steam-In-Place (SIP) Qualification Services
Compounding Vessels, Transfer Lines, Fill-lines, Portable Tanks, WFI systems.
- Steam Quality Testings
Dryness Value, Superheat, and Non-Condensable Gasses.
- Oven Qualification Services
Vacuum Ovens, Benchtop Ovens, Process Ovens.
- Heat Tunnel Qualification Services
- Ramping Chamber Validation Services
Controlled Rate Freezers, Blast Freezers, Shipper Container Validation Chamber.
- Shakers & Stirrers Qualification Services
- Centrifuge Qualification Services
- Water Bath Qualification and Bead Bath Qualification Services
- Glass Washer and Parts Washer Validation Services
Temperature mapping, Soil test, Conductivity, 21 CRF Part 211, ISO 13485 guidelines.
- Lyophilizer Validation / Freeze Dryer Validation Services
Shelf mapping, Product characterization mapping.
Equipment Qualification and Validation Services Provided
Our goal it to build long-term relationships by providing the best solution for any situation.
List of services provided:
- Validation Project Management
- Validation Planning
- Validation Staffing
- Validation Consultation
- Validation Training
- Project based validation services and defined Scope-Of-Work (SOW) validation projects
- Temperature Mapping Services
- Do It Yourself (DYI) Temperature Mapping
- Relative Humidity Mapping (RH)
- Carbon Dioxide Mapping (CO2)
- IQ / OQ / PQ Qualification and Validation Protocol Generation
- IQ / OQ / PQ Validation Report / Qualification Report Generation
- Commissioning, Qualification, Validation Services (CQV)
- Factory Acceptance Testing Services (FAT Testing), Site Acceptance Testing Services (SAT Testing)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Continuous Qualification (CQ) / Requalification (RQ)
When to use Ellab
Validation and Equipment Qualification situations, in which Ellab is typically utilized:
Unexpected projects: We at Ellab understand that projects can occur unexpectedly, which is why we are flexible and committed to meet any given timeframe. We can react quickly and supplement staff, bring our own validation equipment and handle the project as independently as required.
Large projects: We can handle projects that are large in scale on condensed timelines due to the skill of our staff and the quantity of validation equipment we have available.
Specialized Expertise: Our team is highly trained with a wealth of knowledge and experience. We are often hired to perform some of the more complicated qualifications, such as autoclaves and Steam-in-Place.
Contract Validation Staffing/Staff Augmentation: We can provide staff for short-term and long-term durations for situations that require an extra pair of hands at facilities.