Qualification of Nitrogen Gas Producing System-for Sterile Manufacturing
Introduction
Nitrogen gas is widely used in pharmaceuticals as it is a inert gas. Due to this property nitrogen saves the degradation of product.
At the...
PQ of Blender (V-shape)
V Blender is used for mixing of active ingredients along with excipients and lubricants.
PQ of V Shaped Blender
Prerequisites
Verify all SOPs are available and...
PQ Methodology and Validation Matrix for Compression Machine
VALIDATION PLAN AND METHODOLOGY
Performance of the Double Rotary Tablet Compression Machine shall be tested at extreme and optimum operation conditions, which are identified as...
Personnel Qualification for Gowning Procedure -Aseptic Area
Training of Personnel:
All the personnel working in the aseptic processing are should be trained for personal hygiene.
The operator or chemist should be...
Establishing the minimal and maximal optimum speed during qualification of blender
Procedure for establishing minimum optimum speed:
Run the machine as per the standard operating procedure. Set the lowest RPM possible and run the machine for...
Design Qualification of Vertical Laminar Reverse Flow Powder Containment Station
OBJECTIVE
To design, engineer and supply the Vertical Laminar Reverse Flow Powder Containment Station to provide assurance that the machine is manufactured as...
Equipment qualification..Basic approach..!!!
Equipment qualification
Equipment qualification performed to “Establish confidence that process equipment and ancillary system are capable of consistently operating within established limit and tolerance”
User requirement...
