ENVIROMENTAL CONTROL FOR PARENTERAL PREPARATION

ENVIROMENTAL CONTROL FOR PARENTERAL PREPARATION

[Air Handling, Air Conditioning and Refrigeration]

Parenteral preparation:  Parenterals (para enteron-beside the intestine) are sterile, pyrogen free preparations injected through skin or mucous membrane into internal body compartment.

Enviromental Control :  

Essential for manufacture quality product.

CONTROL OF :

·         Airborne nonviable particulate monitoring

·         Airborne viable contaminant monitoring

·         Viable contaminant monitoring of surfaces

·         Viable contaminant monitoring of personnel

·         Temperature and humidity monitoring

·         Pressure differential monitoring

·         Air Velocity, Air Changes, Filter Integrity

v  HVAC

[    [  Heating, Ventilation, Air, conditioning]                                                                          System necesrary  to assure the quality and safety of the pharmaceutical product.

1.       Temperature : 68°F (20°C) and 75°F (25°C)
2.       Humidity : 30% relative humidity (RH) and 60% RH
3.       Pressure : A slightly positive pressure to reduce outside air infiltration.
4.       Ventilation: Rooms typically have several complete air changes per hour

The manufacturing environment is critical for product quality:

1. Light

2. Temperature

3. Humidity

4. Air movement

5. Microbial contamination

6. Particulate contamination

7. Uncontrolled environment can lead to product degradation

Enviromental control:

1)  For asceptic filling  :                                                                      

2) For non-asceptic filling: 

Designing of Aseptic Area: