Saturday, November 18, 2017

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...

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...

Performance Qualification – LAF (Laminar Air Flow)

Laminar Air Flow (LAF) Work Station is capable of maintaining a particulate free work area even when operated in an uncontrolled environment. This is...

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...

Basics of Equipment Qualification

Equipment used in pharmaceuticals dosage form manufacturing need to observe continuous qualification to monitor its performance. Need of Qualification To manufactured a quality product Proof “suitability...

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...