HVAC

Product Details

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