Services



VALIDATION

Pania’s Process Validation Services involve a comprehensive and in depth exploration and evaluation of every aspect of the manufacturing environment







QUALIFICATION

Pania validation consultants will help you design, redesign, improve, select and install equipments



Validation Services

Pania Validation Group can offer you following validation services:


Clean room 1


  • Validation Master Plan (VMP)
  • Equipments cleaning validation
  • Clean room cleaning validation
  • Sterile and non-sterile process validation
  • Microbiological validation for sterile lines
  • Media fill for sterile lines


Qualification Services

Development of URS/ Risk assessment/ DQ/ IQ/ OQ/ PQ protocol, execution and repot for following equipment and systems:



CLEENROOMVALIDATION

Solid dosage form equipment:

  • Blister Machine
  • Tablet Press machine
  • Capsule filling Machine
  • Negative isolators
  • Down flow booth
  • Blender
  • Tablet coater (Only PQ)
  • Mix and granulation machine (Only PQ)
Sterile filling equipment:
  • Autoclave & oven (including microbiological validation)
  • Positive and negative pressure isolators
  • Compounding vessel
  • Sterile filling line
  • Laminar air flow & Hoods
Systems & utilities:
  • Hygienic HVAC
  • Clean room (EU class A,B,C,D)
  • Cold room
  • Warehouse (Temperature mapping)
  • Pharmaceutical gases (Compressed air, Nitrogen & other gases)
  • Pharmaceutical water purification systems ( Purified generator and distribution, Water for injection generator and distribution, Clean steam generator and distribution)