Onsite cGMP Environmental Chamber Validation and Qualification Service
Ellab is a provider of onsite cGMP environmental chamber validation and qualification services, which include temperature and humidity mapping. Environmental chambers are highly accurate and stable enclosures used to store and/or test products and materials in pharmaceutical, biotechnology, medical device and healthcare industries. Environmental test chambers are also known as climatic chambers or climate chambers. Examples of environmental chambers include liquid nitrogen freezers, cryogenic freezers, ultra-low freezers, laboratory freezers, laboratory incubators, ICH stability chambers and CO2 incubators. Commonly, these units are viewed as walk-in rooms such as walk-in freezers, walk-in cold rooms, walk-in refrigerators, walk-in temperature rooms, walk-in ICH stability rooms and temperature / humidity controlled warehouses. In highly regulated environments that need to comply with current Good Manufacturing Practices (cGMP) or current Good Laboratory Practices (cGLP) it is often required to map your environmental chambers to ensure that your product or sample is in the desired environmental conditions.
Common Types of Environmental Chambers Validated & Qualified to cGMP / cGLP standards:
Outsourcing qualifications to Ellab Validation Service team
Often our clients choose to outsource qualifications to Ellab’s laboratory validation service team. For new environmental chambers our clients request that we generate the validation protocols and perform a full IQ/OQ/PQ, which includes temperature mapping. After the IQ/OQ/PQ qualification, Ellab can either hand over the data for the client to generate their own reports or we can generate the final reports including summary. Validations for existing environmental chambers are often more limited due to the unit being in use. For existing chambers more companies are moving to periodic revalidations anywhere from one to five years in frequency. In revalidation circumstances Ellab can either generate the validation protocol or use the client’s current protocol. We would then perform the qualification activities to validate the environmental chamber, which often include temperature mapping. At the conclusion we can provide you with the mapping data for you to generate the final reports or we can generate the reports and summary for you. We can be flexible based on your particular needs.
Depending on your particular user requirements we can perform:
- Ellab Validation Protocol Development with an option of utilizing the Client’s protocol
- Installation Qualifications (IQ)
- Operational Qualifications (OQ), including temperature mapping using Ellab’s validation equipment
- Performance Qualifications (PQ), including temperature mapping using Ellab’s validation equipment
- Ellab qualification report generation including summary reports and option of handing over of data for the Client to complete reports
We have locations strategically placed throughout North America staffed with dedicated engineers that have extensive experience in life science industries including: pharmaceutical, biotechnology, medical device, clinical, vaccine and industrial applications. Our team leverages an expansive supply of Ellab validation equipment specifically designed for environmental mapping of various conditions, allowing us to complete projects in an expedited manner. Our validation engineers will travel to your facility and perform the validation and/or qualification of environmentally controlled storage areas according to Good Manufacturing Practices (cGMP) or Good Laboratory Practices (cGLP) in order to meet your User Requirement Specifications (URS).
These areas are critical as they are used to store cGMP raw materials, intermediate and finished products. Typical environmental conditions verified in controlled storage areas include thermal (temperature) uniformity mapping, relative humidity (RH%), carbon dioxide (CO2), rotation and light. You can expect a high level of expertise pertaining to execution and quality documentation. Ellab will be your Subject Matter Experts (SME) with a high level of integrity and reliability.
As the manufacturer of the world’s most advanced thermal validation equipment, we are uniquely positioned to utilize our industry-leading temperature mapping systems alongside our experienced team of engineers. Our equipment is used for qualifying environmental chambers including Controlled Temperature Chambers (CTC), Controlled Temperature Units (CTUs), Controlled Temperature & Humidity Chambers and other Controlled Environmental Test Chambers & Rooms. Due to the accountability of using the equipment we manufacture, Ellab has the ability to deliver a high-quality turn-key service providing unmatched confidence in the work performed at your facility. We form strong relationships with our clients with the goal of becoming your preferred partner for validation services. We look forward to the opportunity to work with you.
Onsite Qualification Process & methodology for cGMP Validation of Environmental Chambers
- Working together as partners, Ellab and our Clients identify and define the qualification requirements necessary to be verified through testing to ensure that the appropriate qualification activities are performed based on their needs. A system’s requirements are established by considering several factors that stem from the owner’s intended use and the risk associated with the unit functioning properly. For controlled environments, the extent of validation performed and stringency of the acceptance criteria take into account factors such as location (cGMP, cGLP, clean room area), condition and history of the equipment (new, used, relocated), specifications of materials being stored, impact to the product in the event of a failure and many other potential factors.
- There are three primary options when it comes to validating your controlled storage environment. The first is for a new or relocated chamber requiring a full IQ/OQ/PQ qualification. The second option is a periodic re-qualifications (RQ) or continuous qualifications (CQ) of existing and operational chambers & rooms. A third option is the decommissioning of a system at the end of its lifecycle.
- We will work with you in the preparation of validation protocols with review and execution of validation protocols as well as compiling validation protocols, qualification test documents and qualification report information. Ellab will be your Subject Matter Experts (SMEs) to help develop a temperature mapping strategy.
Options when validating your controlled storage environment:
- New or Relocated Chamber Validation (CTUs)
- Existing Chamber Qualification - Periodic Review - Re-Qualification/Re-Validation/Re-Mapping
- Decommissioning Chamber Qualification (CTU)