In pharmaceutical manufacturing, how space conditions impact the product being made is of primary importance. The pharmaceutical facilities are closely supervised by the authorities, who require manufacturing companies to conform to cGMP (current Good Manufacturing Practices). These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs to take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix ups, and errors.

The GMP for HVAC services embraces number of issues starting with the selection of building materials and finishes, the flow of equipment, personnel and products, determination of key parameters like temperature, humidity, pressures, filtration, airflow parameters and classification of cleanrooms. It also governs the level of control of various parameters for quality assurance, regulating the acceptance criteria, validation of the facility, and documentation for operation and maintenance.

What can HVAC do?

HVAC system performs four basic functions:

1. Control airborne particles, dust and micro-organisms – Thru air filtration using high efficiency particulate air (HEPA) filters.

2. Maintain room pressure (delta P) – Areas that must remain “cleaner” than surrounding areas must be kept under a “positive” pressurization, meaning that air flow must be from the “cleaner” area towards the adjoining space (through doors or other openings) to reduce the chance of airborne contamination. This is achieved by the HVAC system providing more air into the “cleaner” space than is mechanically removed from that same space.

3. Maintain space moisture (Relative Humidity) – Humidity is controlled by cooling air to dew point temperatures or by using desiccant dehumidifiers. Humidity can affect the efficacy and stability of drugs and is sometimes important to effectively mould the tablets.

4. Maintain space temperature - Temperature can affect production directly or indirectly by fostering the growth of microbial contaminants on workers.

Each of above parameter is controlled and evaluated in light of its potential to impact product quality.

What HVAC can’t do?

1. HVAC cannot clean up the surfaces of a contaminated surfaces, room or equipment

2. HVAC cannot compensate for workers who do not follow procedures

Our efficacy HVAC system is designed on proper consideration of the following factors:

1. Building construction and layout design

2. Defining the HVAC requirements system-wise and then room-wise.

– Cleanliness level

– Room temperature, relative humidity

– Room pressure

– Air flow pattern

3. Cooling load and Airflow compilation

4. Selection of air flow pattern

5. Pressurization of rooms

6. Air handling system

7. Duct system design and construction

8. Selection, location and mounting of filtration system

9. Defumigation requirement

10. Commissioning, performance qualification and validation

11. Testing and validation

12. Documentation

Sterile area clean rooms have the following distinct characteristics:

1. Air to be be of a high microbial quality.

2. Air handling system is provided with a central HEPA filter bank along with mandatory terminal filters in order to extend the life of terminal filters.

3. The filtration regime is generally three stages with two stages of pre-filters, 10 micron

(EU 4), 3 micron (EU 8) and one central final filter 0.3 micron (EU 12) along with terminal HEPA filter.

4. All sterile critical operations to be in a laminar flow work station.

5. Critical areas have a positive pressure differential relative to adjacent LESS clean areas: a positive pressure differential of 0.05 inch of water (12.5 Pa) is acceptable.

6. Supply air outlets are provided flush at the ceiling level with perforated stainless steel grilles and terminal absolute filters. Return air grilles to be provided at the floor level with a return air riser for better scavenging

7. Walls, floors, and ceilings for cGMP areas are to be constructed of smooth, cleanable surfaces, impervious to sanitizing solutions and resistant to chipping, flaking, and oxidizing.

Key Words:

Pharmaceutical Machinery, Pharmaceutical Engineering, Pharmaceutical Equipment,
Packaging Machinery, GMP Machinery, Pharmaceutical Industry, Pharmaceutical Technology

cGMP Service, cGMP Solutions, cGMP Validation