July 1, 2021
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?
- 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.
- 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.
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
- 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