​In addition to equipment maintenance, HRCare teams execute installation, operation, performance, and re-qualification protocols in your lab. At your convenience—accordin​​g to your timetable. Our USP-trained chemists run calibrator tests and ensure that every dissolution tester is primed and ready for workload and performance.​​

HRCare also provides ASTM E2503-13 mechanical qualification and extended warranty programs. While we continue to recommend and provide instrument performance qualification with the USP Performance Verification Test (PVT), a rigorous mechanical calibration also carries benefit.

Certificates of Conformance​​

ASTM Certificates of Conformance (COCs) are available for USP accessories (vessels, paddles, baskets, and shafts), detailing all relevant ASTM dimensions and tolerances. These quality accessories, with corresponding COCs, are required for ASTM. Certificates of Analysis (COAs), recording actual dimensional measurements, are available for USP accessories on special order. Please note that a COA is not required for ASTM when a COC is available. A convenient “pre-scan” to evaluate previously installed e​quipment is available prior to full ASTM qualification.

To ​support laboratories that desire to comply with the new ASTM standard, we provide a complete ASTM mechanical qualification and certification program for our equipment and accessories. HRCare ASTM mechanical qualification is available for SR8-Plus and Vision dissolution testers, including units already installed and in use.

“Audit-proof” documentation means we stand behind everything we certify. You have confidence in passing USP, US FDA, cGMP, GLP and other international regulatory protocols and audits. Our comprehensive validation documents provide your management and metrology team with a complete package for easy audit approvals.

The ASTM Certificates of Conformity policy clarifies the type of quality certificates that will be included with many of the products.

The Q-Pak™ addresses manufacturers’ and USP / US FDA recommendations for dissolution and diffusion instrument IQ, OQ, and PQ (Installation, Operation, and Performance Qualifications). This unique guideline directs the user through instrument qualification and documentation of key elements of functional validation. Combined with our easy-to-use calibration tools, the Q-Pak can ensure optimum dissolution performance and maximum regulatory compliance.

Q-Paks are ideal guidelines to help develop document system qualification for audit trail.​

​HRCare service, maintenance, installation, and validation programs are designed to bring you the confidence of “audit-proof” dissolution lab validation. HRCare programs are available to all USA ​customers. Similar programs ar​​e available worldwide

Service & Maintenance

Installation & Validation​

Extended Warranty (EW)​

​User manuals and other operation instructions can be found on individual product pages or in the Document Library​.