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isoLabserv Ireland
ISO 9001:2015 Certification

Dissolution Systems

NLG Labserv are able to provide engineers with over 10 years experience at delivering full Maintenance, Qualification and PVT plans on all makes of dissolution.

Namely Vankel, Sotax, Distek, Caleva and pharmatest.

During those years they’ve received extensive training on USP Apparatus 1,2 and 4. and trained directly by USP to perform what was the Prednisone and Salicylic acid Chemical PVT. ( Performance Verification test)

Naturally, this has led to an in-depth knowledge of the USP Chapter 711 which sets out the criteria for the DQ of all App 1 ,2 and 4 dissolution systems. (USP Certs for the engineers can be made available)

Recently the FDA has issue its guideline document DPA-LOP.002. This outlines the FDA requirement for the Full Mechanical Qualification of an Apparatus 1 and 2 bath. The USP have removed the Salicylic Acid tablet from the PVT test andĀ altered their acceptance criteria for the Prednisone tablet test only. It is now common practise to have an Apparatus 1 and 2 dissolution system qualified using the FDA and now USP agreed MQT ( Mechanical Qualification test). End users then follow this with the USP specific PVT using Prednisone tablets and utilising the New USP

1. Basic level – PM/OQ ( for non compliant labs or R&D)

OQ is
Speed of rotation
Shaft, basket and paddle wobble
Depth check
Shaft verticality
Temperature of bath and vessels

2. GMP level – PM/MQT ( for Audited and compliant labs ) FDA MQT compliant

OQ is
Speed of rotation
Shaft, basket and paddle wobble
Basket and Paddle Depth check
Shaft verticality
Vessel verticality
Bath levelness
Shaft centering ( including Basket and paddle if detachable)
Temperature of bath and vessels

3. GMP level – PM/MQT & USP Performance Verification test ‘PVT’ ( for Audited and compliant labs )

All of section 2 but with additional PVT testing
a) PM/MQT & PVT Paddles Only
b) PM/MQT & PVT Basket Only
c) PM/MQT & PVT Paddles and Basket

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