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