Dissolution Instrument For Research And Quality Laboratories

Overview
Chrom Technology supplies and supports the dissolution instrument used for solid dose studies in R And D and QC. We install, qualify, calibrate, and maintain the instrument with audit ready documentation and predictable timelines.

What We Supply

• Dissolution instrument configured for Apparatus 1 basket or Apparatus 2 paddle with six or eight vessels.

• Options for Apparatus 3 reciprocating cylinder and Apparatus 4 flow through.

• Temperature control, degassing, vessel covers, paddles and baskets, centering tools, and alignment gauges.

• Automated sampling with fraction collector or online UV or HPLC interface.

• Control and data software with 21 CFR Part 11 capability when required.

Services Included

• URS and specification, method fit assessment, and RFQ support.

• FAT and SAT coordination.

• DQ, IQ, OQ, and PQ with complete protocols and reports.

• Traceable calibration of temperature, rotation speed, shaft alignment, centering, and wobble.

• Preventive maintenance, emergency repair, and spare parts management.

• Operator and maintainer training with SOPs.

Typical Uses
Formulation screening, method development, robustness studies, routine QC dissolution to USP 711 and 1092, IVIVC research, and automated sampling to reduce manual error.

Deliverables
Qualification protocols and reports, temperature and RPM calibration certificates, alignment and centering records, sampling accuracy verification, maintenance logs, and change control documentation.