Equipment Qualification & Validation Services
Ellab’s equipment qualification and validation services are available in the USA, Canada, Europe and the Philippines. We offer a wide variety of validation services to meet complex requirements in regulated environments.
Experienced team of Validation engineers
Our equipment qualification and validation services consist of a highly trained team of professionals that can be trusted to provide solutions for all requirements. The experienced service teams are independent, follow good documentation practices and has access to a large fleet of Ellab validation systems to perform work efficiently. Ellab is committed to providing world-class services, which leverage our expertise to meet all of your compliance requirements.
Meeting Industry Standards
Standardized regulatory requirements acknowledged by the governing authorities must be met wherever products are sold. These requirements are 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). To help meet industry standards, our engineers leverage our internal quality management system (QMS) which includes standard operating procedures (SOPs), processes and data management to ensure that we are holding ourselves to the highest level of quality.
Validation Equipment Accountability
One significant advantage that Ellab offers as a service provider is that we manufacture the validation systems our team uses for validation and equipment qualifications. This offers unmatched equipment accountability and also provides access to a near limitless supply of the best validation equipment available. This allows us to achieve industry leading efficiency while providing the best results for your project.
Providing the best solution for any situation
Our goal is to build a long-term relationships by providing the best solution for any situation, whether it be utilizing our validation services, purchasing validation equipment or providing validation rentals.
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
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
Stability storage rooms, Walk-In Cold Rooms, Walk-In Freezers.
- Warehouse Validation / Qualification / Mapping
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
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
Cycle Development, Load temperature mapping, Endotoxin challenge testing and Fixed load and variable load approaches.
- Steam-In-Place (SIP) Qualification
Compounding Vessels, Transfer Lines, Fill-lines, Portable Tanks, WFI systems.
- Steam Quality Testing
Dryness Value, Superheat, and Non-Condensable Gasses.
- Oven Qualification
Vacuum Ovens, Benchtop Ovens, Process Ovens.
- Heat Tunnel Qualification
- Ramping Chamber Validation
Controlled Rate Freezers, Blast Freezers, Shipper Container Validation Chamber.
- Shakers & Stirrers Qualification
- Centrifuge Qualification
- Water Bath Qualification and Bead Bath Qualification
- Glass Washer and Parts Washer Validation
Temperature mapping, Soil test, Conductivity, 21 CRF Part 211, ISO 13485 guidelines.
- Lyophilizer Validation / Freeze Dryer Validation
Shelf mapping, Product characterization mapping.
Equipment Qualification and Validation 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)
- Continuos Qualification (CQ) / Requalification (RQ)
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. With a global view, Ellab can assist with identifying and meeting the desired regulations worldwide.
List of industries served for validation and qualification 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
- Food and Beverage
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.