How to safely do In-Process Quality Control for High Potent powder, tablets or capsules?

How to safely do In-Process Quality Control for High Potent powder, tablets or capsules?

What are the issues?

How to protect the QA team during in-process testing when:

  • High Potent tablets are dusty
  • High Potent Capsules can break open or leak
  • Highly Potent API powder must be checked

How to make an isolator fit in a small room?

FPS Solution:

  • L-shaped isolator gives maximum room for testing but still fits in small room
  • All testing instruments are contained in the 300 ng/m3 isolator
  • A printer for each system is placed outside for easy and safe access

Benefits of FPS Solution:

  • No risk of exposure for the operators during all operations
  • Special design an “L” shape fits in small room
  • Sliding drawers for printers (outside the isolators): easy access

 

Description of FPS custom solution

  • IPQC isolator is used for testing tablets or capsules in the production area for QC (Quality Control) analysis and approval.
  • Structure:
    • airlock to introduce bags of products
    • L-shape to maximize the length of the working chamber gives ample room for all instruments:
      • Analytical balance
      • Moisture analyzer
      • Weight variation system
      • Hardness tester
      • Friability tester
      • Automatic disintegration tester
  • Each instrument has a printer which is accessed easily & safely outside the isolator in dedicated sliding drawers.

Process:

The IPQC isolator is used to perform the main analysis of on the samples (powder, tablets or capsules).

The isolator system is designed to guarantee the CPT = 300 ng/m3 – 8h TWA

Process steps:

  • Loading: products packaged in small crimped bags are loaded into the airlock
  • Product is moved in the dispensing chamber for testing
  • Waste (single-use tools & bags of analyzed products) is put in a continuous liner
  • CL closed with a welding machine to reach the containment level

 

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