A well designed Heating, Ventilation and Air-Conditioning (HVAC) system play an important role in ensuring the manufacture of quality pharmaceutical and microelectronic products and will also provide comfortable conditions for operators or any personnel that staying in (or passing through) the area supplied with air from HVAC system.
In comfort air-conditioning (such as hotels, restaurants, shopping malls, business offices etc.), HVAC system should mainly ensure pleasant environment for the people staying inside.
For the pharmaceutical production, the architectural components of the HVAC systems have an effect on performances such as room pressure differential cascades, prevention of contamination and cross-contamination control. Those performances should primarily ensure product protection, personnel protection and environmental protection.
HVAC Qualification
The qualification of the HVAC system should be described in a Validation Master Plan (VMP) – mainly applicable in pharmaceutical and related industries.
It should define the nature and extent of testing and the test procedures and protocols to be followed.
Stages of the HVAC system qualification should include Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
Critical and non-critical parameters should be determined by means of a Risk Analysis (RA) for all HVAC installation components, subsystems and controls.
Our team of experts is specialized for performing HVAC qualification activities, including design and development of custom VALIDATION AND QUALIFICATION DOCUMENTATION and execution of all activities, together with documented measurements of critical HVAC system parameters, such as:
- Classification of air cleanliness by particle concentration
- Installed filter system leakage test
- Supply airflow rate and air change rate for non-unidirectional airflow installation
- Supply airflow velocity and uniformity of velocity for unidirectional airflow installation
- Temperature test
- Humidity test
- Air pressure difference test
- Airflow direction test and visualization
- Recovery test
Periodic requalification of critical parameters should be done at regular intervals (e.g. annually). Requalification should also be done when any change, which could affect system performance, takes place.
FAQs
The three major components of a cleanroom validation are installation qualification (IQ); operational qualification (OQ); and performance qualification (PQ).
What is IQ oq and PQ validation? ›
IQ stands for Installation Qualification, OQ for Operational Qualification, and PQ for Performance Qualification. The purpose of process validation is to establish documented evidence that the production equipment is correctly installed, operates according to requirements, and performs safely.
What are the qualifications for a clean room? ›
The definition for Cleanroom Qualification is “The overall process to assess the level of compliance of a classified cleanroom with its intended use.” That is, classification is a part of qualification.
What is the IQ oq PQ protocol? ›
Validation protocols are a method of establishing documented evidence that demonstrate a high degree of assurance that a cleanroom facility will consistently perform to the original specification in the URS, while also meeting all regulatory requirements.
What is the operational qualification of a clean room? ›
The Operational Qualification (OQ) which is performed while the cleanroom is “At Rest”. This means that all equipment and supplies are in the area and the equipment is functioning properly. Personnel are not utilized in this phase.
What does pq mean in validation? ›
PQ stands for Performance Qualification and is the last phase of the validation process. Here, the equipment will run several times under normal operating conditions and its functions will be challenged.
What is PQ validation? ›
Performance qualification (PQ) The performance qualification phase is the final step in the validation process. This phase ensures that equipment and systems consistently perform at levels that meet predefined requirements and specifications.
What is ISO 9 clean room requirements? ›
ISO 9 is considered normal room air. These rooms have a known sampling with 35,200,000 or fewer particles measuring 0.5 microns, 8,320,000 or fewer particles measuring 1 micron, and 293,000 or fewer particles measuring 5 microns.
Do cleanrooms need to be certified? ›
Cleanrooms can be under positive or negative pressure. A cleanroom certification must be routinely performed to ensure accordance with client, INDUSTRY, and regulatory specifications to verify the facility is performing within operational limits.
What are the levels of clean room certification? ›
This ISO standard includes these clean room classes : ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 and ISO 9. ISO 1 is the “cleanest” class and ISO 9 is the “dirtiest” class. Even if it's classified as the “dirtiest” class, the ISO 9 clean room environment is cleaner than a regular room.
Each of these procedures can be standalone documents or combined (i.e. IQ and OQ can be combined into IOQ. In other situations, PQ may be combined with OQ or combined with Process Validation). However, in every case, the protocols need to be prepared specifically for the system or equipment being qualified.
What is the difference between qualification and validation? ›
Validation is achieved and is directly linked to the process, whereas qualification is performed and is directly linked to the equipment, instruments, and software. That means methods or procedures are validated, whereas equipment, instruments, or software is qualified.
What is the difference between verification and validation? ›
How Do Verification and Validation Differ? The distinction between the two terms is largely due to the role of specifications. Validation is the process of checking whether the specification captures the customer's requirements, while verification is the process of checking that the software meets specifications.
How often must a clean room be certified? ›
Understand your certification report
All classified areas, including the hood, must be recertified every 6 months. This report includes validation of the air quality and airflow within the compounding area and is a key indicator that your cleanroom is in good working order.
What are the OSHA requirements for clean rooms? ›
Cleanrooms require specific attire, personal protective equipment (PPE), and the use of specialized equipment and chemicals. While modern air handlers manage the particle count, YOU are the best source to control cleanroom safety.
What is the difference between qualification and validation with example? ›
Validation is achieved and is directly linked to the process, whereas qualification is performed and is directly linked to the equipment, instruments, and software. That means methods or procedures are validated, whereas equipment, instruments, or software is qualified.
Is PQ same as process validation? ›
In other cases, the PQ can overlap (even partially) with the PV (Process Validation), but it must be considered that while the PV checks the specific operating parameters of a single product, the PQ must check the extreme operating parameters of equipment use, so that the PVs of several products can be used to make up ...
Who approved IQ and OQ? ›
That's why FDA 21 CFR 820 states that: “Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures.” And that's where your IQ, OQ, and PQ processes come in.
What is the difference between SAT and IQ OQ? ›
SAT is a test that verifies if the software installed on the device meets all requirements, while IQ OQ checks whether or not the hardware components have been properly installed and configured for optimal performance.
