Qualification Documentation (IQ/OQ) for Terra Universal System

Why do I need to perform an Installation Qualification (IQ) or Operational Qualification (OQ) on my cleanroom or equipment?

Validation, executed as a global exercise, is a method of establishing documented evidence, with a high degree of assurance, that the manufacturing process will consistently yield a product of predetermined quality. If a manufacturer fails to execute a comprehensive equipment qualification, they may experience rising product failure rates, production inefficiencies, employee miscommunication due to incomplete standard operating procedures and, potentially, a loss of market share. This risk can be mitigated by performing an IQ/OQ/PQ on your cleanroom and equipment.

Am I required to perform an IQ/OQ/PQ on my equipment?

(21 CFR 820): FDA requires all equipment used in critical manufacturing processes to be validated with an IQ/OQ/PQ. During FDA visits, FDA officials will comprehensively review all executed protocols.

What are the benefits of an IQ/OQ/PQ?

• Reduces production costs of reworking non-conforming products.
• Helps meet regulatory requirements; the FDA may require the manufacturer to perform a process validation if their current process is not fully verified.
• Ensures smooth FDA site audits.

The IQ ensures that all equipment has been installed correctly with applicable inputs (e.g. power, compressed air), all environmental conditions have been met (e.g. temperature, humidity, air quality), all required calibrations have been performed (e.g. pressure gauges, temperature gauges), all safety measures have been implemented and the equipment has been entered into the manufacturer’s PM (Preventive Maintenance) and calibration systems. The IQ protocol ensures that all components, per the manufacturer’s equipment manual, are verified and the equipment meet the user’s needs.

The OQ demonstrates that the protocol produces a conforming product throughout the range of process inputs including environmental parameters (e.g. temperature, pressure, time), raw material specifications, production logistics (e.g. multiple users) and duplicate sets of equipment (e.g. multiple production lines). The OQ includes worst-case scenarios to demonstrate that the entire range of parameters will produce an acceptable product. Operator training on the manufacturing procedures is also included. The OQ protocol ensures that all equipment parameters have been defined and recorded.

The PQ demonstrates that the process consistently produces an acceptable product. In most cases, three manufacturing lots are produced at the nominal process parameters. The three-lot industry standard stems from a statement in the FDA’s preamble to the Quality System Regulation. Although this practice has been widely adopted by industry, the minimum number of lots required for a PQ is the responsibility of the manufacturer and should be based on the specific production logistics, such as the number of manufacturing shifts and production lines. The PQ requires that all operating procedures be approved and all personnel trained prior to execution.

Certification of a cleanroom or processing equipment can be as simple as performing a smoke study or a HEPA filter leak test. Certification testing protocols often don’t account for variables that may affect the quality of a company’s product. An IQ/OQ protocol accounts for all known variables, performs a deeper verification of the equipment, and integrates all documents into a single, comprehensive file. The following tests can also be included in the IQ/OQ as part of a complete package:

• Sensor Calibration: All sensors and gauges must be calibrated and documented with a date-stamped calibration sticker. The validation process requires proof that each system has been tested and will provide the same output of results during regular operation.
• Viable Surface and Air Testing: A proper IQ/OQ protocol includes a drafted and tested cleaning procedure. To ensure the cleaning procedure was effective in removing all viable microbes, a viable sampling test is performed on the same day as the IQ/OQ validation.
• Airflow Visualization Study: A smoke study is required to show the air flow pattern inside a process enclosure, such as a glove box or cleanroom. Air flow laminarity, uniformity, turbulence, and air velocity are evaluated during the study.
• Non-Viable Particle Counts: A test specifically for non-viable particulates prone to cause cross-contamination and increase product failure rates.
• HEPA Filter Leak Testing: A test to ensure the HEPA filters are not damaged, the filter media is not saturated and the filter effectively captures particulates per stated specifications.

Once you have purchased the IQ/OQ package, a Terra Universal validation specialist will get in contact and set up a phone call. During the initial phone call, all customer requirements will be discussed and validation questions answered. After the phone call, meeting minutes of the conversation are sent, and a timeline for execution is created. The protocol is then drafted and sent to the customer for approval. Once approved, flights are booked (if applicable), and Terra Universal validation specialists will arrive on site to execute the validation protocol. Once complete, a full report along with all data is sent to the customer for approval.

Does my equipment need an IQ/OQ?

IQ/OQs are recommended for equipment such as hoods, gloveboxes, cleanrooms and any major equipment involved with the production or development of your product. An equivalent of an IQ/OQ for a cleanroom is called a Construction Qualification (CQ).

Validation Cheat Sheet

• FS - Feasibility Study: A study that most engineers perform to check if the equipment or process works per their specifications or requirments
• SOW - Statement of Work: When engineers need to perform feasibility testing at a vendor, they write a document called a SOW. This SOW will define: purpose, scope, timeline, what to test, and a report from the vendor. Once the SOW has been agreed upon by both parties, the PO is sent the vendor and feasibility testing can start.
• URS - User Requirment Specification: When engineers need to design a custom piece of equipment with a vendor they draft a URS or sometimes it is also called an Equipment Specification (ES). This document essentially is a contract between the company writing it and the vendor they are working with. It defines all of the requirments the company wants the vendor to built to. Everything from technical requirments to Project timeline requirments and expectations are documented in this. Project starts once this URS has been drafted & approved by both the company and the vendor.
• FAT Factory Acceptance Testing: Sometimes your customers may ask you to draft a FAT protocol and help them execute it. A FAT protocol is always done at your site. The customer wants to know if the equipment they purchased is works per all of their requirments before they accept it to be shipped to thier site. This is usually performed on custom equipment and not on Off the shelf standard equipment but can be. The need for an SAT protocol and execution is typically discussed in the begining of the project. An FAT protocol is almost the same as the IQ protocol with regards to what is being tested.
• SAT Site Acceptance Testing: Sometimes your customers may ask you to draft a SAT protocol and help them execute it. A SAT protocol is always done at the customers site. The customer wants to know if the equipment they purchased still works per all of their requirments even after shipping. Sometimes shipping could damage the equipment so the customer wants to check again. This is usually performed on custom equipment and not on Off the shelf standard equipment but can be. The need for an SAT protocol and execution is typically discussed in the begining of the project. An SAT protocol is almost the same as the IQ protocol with regards to what is being tested.
• IQ Installation Qualification: The IQ ensures that all equipment has been installed correctly with applicable inputs (e.g., power or compressed air), all environmental conditions have been met (e.g., temperature or humidity or air quality), all required calibrations have been performed (e.g., pressure gauges or temperature gauges), all safety measures have been implemented and the equipment has been entered into the manufacturer’s PM (Preventive Maintenance) and calibration systems to ensure proper maintenance.
• OQ Operational Qualification: The OQ demonstrates that the process produces conforming product throughout the range of process inputs, which include process parameters (e.g., temperature, pressure or time), raw material specifications, production logistics (e.g., personnel or multiple shifts) and duplicate sets of equipment where appropriate (e.g., multiple production lines). Including worst-case combinations of process parameters is critical to demonstrate that the entire range of process parameters will produce acceptable product. Training of manufacturing operators on the manufacturing procedures is also required.
• PQ Performance Qualification: The PQ demonstrates that the process consistently produces acceptable product. Often this is interpreted as producing three lots at the nominal process parameter(s). This three-lot guidance is based on a statement in the FDA’s preamble to the Quality System Regulation. Although this practice has been widely adopted by industry, the minimum number of lots required for a PQ is the responsibility of the manufacturer and should be based on the specific production logistics, such as the number of manufacturing shifts and production lines.
• CQ Construction Qualification: The CQ Protocol is drafted by an engineer to ensure the new cleanroom built meets all of the requirements set forth by the customer or the URS. This protocol plays a critical role because in addition to verifying the customers requirements, it also reviews the following for the newly built space: Operating procedures, Safety Procedures (Chemical, waste handling, Transport, storage, Spill procedures, labels and signs), Access to space (Change control documents), Gowning Procedures (Gloving, gowning, hand wash, etc.), Cleaning Procedures (daily, weekly, quarterly), Certification (Smoke studies and differential air pressure requirements), Microbial (Viable and non-viable testing), Training procedures, Risk Assessments, Environmental Health & Safety, Electrical Hazards, Cleanroom materials verification, Cleanroom design verification, HEPA Filter Testing.