HVAC Installation Qualification Protocol | The AHU-6 and MAU-1 HVAC system includes Air Handling Unit (AHU-6) and Make Up Air Unit (MAU-1).  AHU-6 was purchased from York International in October 1994.  AHU-6 was designed and installed to supply recirculating air to rooms: 123–125.  MAU-1 was purchased as part of the building and operated to supply make up air to the AHU-6 and rooms 120-125, 111, 113, 114, 117, 118,and both service corridors. The major equipment / components of the AHU-6 and MAU-1 HVAC system include Air Handler Unit AHU-6, Make Up Air Unit MAU-1, Humidifier H-1, twelve (12) reheat coils RHC-1-RHC-9 and RHC-19 – RHC-21 and fourteen (14) exhaust fans EF-1 - EF-12, and EF-15 - EF-17. AHU–6 is a recirculating air handling unit, which provides a constant volume of airflow to rooms 123,124, and 125.  It is equipped with a Pre Cooling coil, Preheat coil and 65% efficiency air filters. AHU-6 provides airflow using outside air from MAU-1 mixed with return air.

MAU-1 provides conditioned air to rooms 111, 113, 114, 117, 118, and 120-125 utilizing 100% outside air. It is equipped with one (1) reheat coil and two (2) cooling coils.  It has 35% efficiency pre-filters and 95% efficiency bag filters, it also utilizes eleven (11) Variable Air Volume controllers VAV-A, B, C, D, E, F, G, H and VAV-j, K and L. one (1) Steam Humidifier H-1 located in the supply air duct downstream from MAU-1 provides humidificationcar a/c compressor repair kit The system is designed to provide personnel comfort. wall mounted air conditioning units costPerformance criteria for the system are:home hvac units for sale Temperature: 70°F ± 5°F This protocol will be performed utilizing 21 CFR 210 & 211, ICH Q-7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, August 2001,.

Upon final approval of this IQ Protocol and Summary Report it will replace the previous IQ study and render it obsolete. The system will also be placed under formal change control in accordance with Company XChange Control Program summarized in Standard Operating Procedure DNAP/QM/012 entitled “Change Control System”. This content is only available to IVT members. Get help maintaining your knowledge in GMP - Qualification. If you are already a member and you do not have access to this article, upgrade your membership. The Concept of Air Handling System Validation The degree of cleanliness of air in the pharmaceutical manufacturing and related operations area should be established depending on the characteristics of products and operations in the area. In order to establish and maintain such standards, careful attention has to be exercised to keep the standards from the stage of design and construction through to the monitoring in the stage of routine operations.

A total air handling system, covering the open air intake, treatment, the supply to the manufacturing area, and the exhaust, should be designed and validated. The handling system contains units or prefiltration, temperature and humidity control, final air filtration, return and exhaust. When the air is supplied to the manufacturing area, care is required in maintaining the required air quality during the operation or at the point of product exposure to the environment. This point is closely related to the layout and construction features of the manufacturing area. The air flow from the critical or most clean area to the surrounding area; that is, the less clean area. For this purpose, rooms used for the manufacturing operation have to be laid out according to the order of the required air cleanliness. In order to maintain the air cleanliness in the area and airflow, the amount of air supplied and exhaust have to be balanced to keep the designed air exchange ratio, airflow pattern, and air pressure differentials.

In each room the operation site should be maintained in the most suitable status. For each purpose, the following items must be carefully controlled. Locations and number of air supplies Locations and number of air exhausts Ratio of air exchange Return ratio of exhaust air Location of local air exhaust, if necessary Airflow pattern at the site of product exposure Air velocity at the point of product exposure These features have to be well designed, installed, validated, and maintained. Critical operation has to be performed under the unidirectional airflow (laminar airflow). Air turbulence deteriorates air quality by intake of air from surrounding less clean areas. The amount of air supplied and exhausted is related to the air pressure differentials. After the system is validated, air quality should be continuously monitored and maintained during manufacturing operations. Filters used for the prefiltration and final filtration should be maintained to operate to their design specifications.

Deterioration of filters is caused by leakage and/or accumulation of particles. The former is tested by periodical integrity test (usually dioctylphthalate DOP test), and the latter is tested by the increase of air pressure differentials between the upstream and downstream sides of the filter. All of the environmentally-controlled areas of pharmaceutical manufacturing and its related areas should meet the requirement of air cleanliness, which is expressed as classification specified by official standards, such as ISO (International Organisation of Standardisation) or FED-STD (U.S federal standard) 209, and/or GMP. The Difference Between Qualification and Validation [Video] Considerations of Sterile Filtration Validation: 21 CFR 211.113 (b) 10 Things To Consider When It Comes To Qualifying Autoclaves The Similarity Between Device Master Records & Chocolate Chip Cookies [Video] The device design once complete, must be adequately transferred to manufacturing.

This is typically accomplished through product specifications, standard operating procedures, work instructions and training. Often a product specification is thought of as a document. The reality is the product specifications should be thought of as an association of written documents. The product specifications typically include: Manufacturing fixtures (jigs and molds) Artwork associated with labels Device Master Record (DMR) The ultimate document to ensure adequate design transfer is the Device Master Record, or DMR. The DMR is somewhat theoretical in that it is really a compilation of all the documents which are needed to realize the product. For that reason, the DMR, is often established as an index which simply lists all of the documents needed to realize the product. Contents of the DMR The DMR typically includes the following documents: Work instructions for device realization Device history records/Forms to generate device history records

Validation Master Plan (VMP) Since these documents may be revising and changing and may be at various distribution points, the DMR typically is an index of all the documents. Chocolate Chip Cookie Analogy One very common analogy is to envision the DMR as a chocolate-chip cookie recipe. If the DMR is complete, by providing the DMR to someone they can make the exact same chocolate-chip cookies. While this is somewhat simplified, it’s an excellent analogy, but in order to make the perfect chocolate-chip cookie we would want specifications for the grade of flour, chocolate chips, sugar and other components. We’d also like to know which equipment was validated, how they are tested/inspected, what are the instructions for each processing step, etc. If we have all the relevant information we can reproduce the cookies exactly. The DMR is the key to any successful design transfer whether it is an internal transfer to manufacturing or a transfer to a Contract Manufacturing Organization (CMO).

The Four Phases of Conducting a Laboratory Investigation [Video] Audit Terminology You Need To Understand [Video] How to Identify and Define Critical Life Science Vendors The Four Phases of Conducting a Laboratory Investigation [Video] The process which will be described here is based on the process discussed in the MHRA’s guidance on Out of Specifications Investigation. When an out of specification, atypical or suspect result is obtained, it is particularly important that all solutions and reagents associated with the test are retained, as this will greatly assist the investigation. The MHRA advocate laboratory investigations should proceed in four phases as follows: Phase I (a) consists of a preliminary review, by the analyst, to determine whether there has been a clear and obvious error or event that caused the OOS, atypical or suspect result. Phase I (b) occurs after phase 1(a) has failed to identify a clear and obvious cause. This is a more detailed investigation by the analyst and supervisor to identify a laboratory assignable cause.