The Crucial Role of Equipment Validation

Equipment Validation is crucially important for Carbon dioxide (CO2) Supercritical Fluid Extraction (SCFE), a technology that lives by its accuracy. Buffalo Extraction Systems engages with clients throughout the equipment validation process, while conforming with the US FDA Part 211 and Part 11, EU Annexe 11, and cGMP standards, and also drafting the necessary documents.

Over the recent past, the CO2 SCFE technology has gathered serious momentum. The process can separate ingredients in their pure form from raw materials. Consumers across the globe are placing a premium on pristine ingredients in the products they consume. Regulations have kept pace with customer inclinations and are getting progressively stringent. As a result, CO2 SCFE is galloping ahead.

Buffalo Extraction Systems has successfully validated and delivered CO2 SCFE units with the essential documentation to clients in diverse industries ranging from Pharmaceutical, Food, and Agriculture to Perfume and Cosmetics.

Products meant for human use have to comply with strict norms so that they serve their intended purpose and are safe. For this to happen, the equipment employed to make these products must conform to certain requirements. Validation checks if the equipment adheres to these requirements.

When the validated piece of equipment is part of a larger process, the validation documents play another key, although indirect, role – that of rapid error detection. If the process output is not as expected, technicians need to pin point the error. They can safely rule out equipment defect because it is already validated [1].



Equipment Validation for Carbon dioxide (CO2) Supercritical Fluid Extraction (SCFE)

Buffalo Extraction Systems implements validation of CO2 SCFE equipment through the following distinct steps which include the documents mentioned therein:

1. Requirement Understanding:

a. Client URS (User Requirement Specification): is the starting point of the validation process and describes what performance the client expects out of the equipment [1]. Customers can either provide the client URS directly or our personnel create it after capturing their requirements.

b. Internal URS: converts client URS into a set of instructions and particulars for our technicians.


2. Design & Development: defines the various components of the equipment, their capacities, materials, location in the overall set up, and other relevant features. Two documents / phases are particularly important:

a. Functional Design Specifications (FDS): describes how the system will perform its expected operation. FDS is the source for functional design requirements.

b. Detailed Design Specifications (DDS): is the source for the detailed design requirements and explains how to build the system.

FDS and DDS are normally verified during qualification or commissioning.


3. Design Qualification (DQ): ensures that the end user’s point of view is incorporated in the design process.


4. Factory Acceptance Testing (FAT): analyses whether the equipment performance conforms with the end user’s specifications. The venue for FAT is the Buffalo Extraction Systems shop floor.

After a successful FAT, the customer and Buffalo Extraction Systems clear the machine for dispatch after certifying that it has been built to satisfy the User requirements (as per URS) and in accordance with FDA and DQ.


5. Installation Qualification (IQ): ensures that the client’s facility provides the appropriate setting for the piece of equipment [1]. IQ is based on DQ [2]. The three most common verifications during IQ are whether the equipment has adequate space allotted in the facility, is connected to the necessary utilities, and is installed with the required software [1].

Technicians also check if the equipment installation:

  • Integrates it with other equipment/systems [2].
  • Complies with qualification protocol and plan [3].
  • Considers all the equipments sub parts [3].
  • Makes arrangements for maintenance, calibration, and cleaning in future.
  • Utilizes the relevant national/international standards for calibration, measurement, and control.
  • Notes all equipment details such as model, serial number, spares, installation date, certificates.


6. Operational Qualification (OQ): is based on IQ. Technicians check if the:

  • Equipment operates as expected, particularly at the extreme operational ends [3] and follows the required operational sequence [2].
  • All equipment components operate correctly.
  • Technicians are correctly trained to operate the equipment.
  • Standard Operating Procedures (SOPs) are finalized and ratified.
  • All results are documented.


7. Performance Qualification (PQ): examines if the equipment/system performs consistently under load as required by the design specifications. Technicians create all the necessary documents for performance verification.




Equipment precision is born at the design qualification stage and matures through the installation, operation, and performance qualification stages. Exhaustive by its very nature, the equipment validation process goes to great lengths in its quest to ensure that a piece of equipment is appropriate from every possible point of view!


Buffalo Extraction Systems has successfully validated a whole range of equipment for the Food, Pharma, Agriculture, Perfume, and Cosmetic Industries. Our technicians engage with clients right from the design qualification stage through to performance qualification.

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  1. IQ, OQ and PQ: Why are they Important in the Manufacturing of Cell and Gene Therapies? CCRM.
  2. Facilities & Equipment: CGMP Requirements. Regina Brown et al. Regulatory Education for Industry (REdI): Focus on CGMPs & FDA Inspections.
  3. GMP Qualifications and Validations in the Pharmaceutical World. IFA Tablet Presses.