Quality & Compliance

At Rara Pharmatech, precision is not a goal—it is our absolute baseline. We engineer sterile-grade equipment that complies with strict global regulatory standards like WHO-GMP, ISO, and CE.

Our Compliance Standards

SS-316L Material Grade

All contact parts are manufactured strictly from premium SS-316L grade stainless steel. We execute Positive Material Identification (PMI) spectrometer checks on every batch to eliminate carbon contamination.

Ra Finish < 0.4 Microns

Our polishing bays ensure ultra-smooth surface finishes. Mechanical and mirror electro-polishing are audited with digital roughness meters to guarantee an average roughness (Ra) value below 0.4 microns.

Audit-Ready DQ/IQ/OQ

We provide full validation lifecycle documentation, including Design Qualification (DQ), Installation Qualification (IQ), and Operational Qualification (OQ) protocols to ensure seamless regulatory audits.

100% Weld & Pressure Tests

All pressure vessels, jacketed systems, and process pipelines undergo thorough hydrostatic testing, dye-penetrant checks, and boroscope weld inspections to guarantee leak-free joints.

Equipment Validation Lifecycle

Step 1

DQ Protocol

Design Qualification checks compliance against user requirements (URS).

Step 2

IQ Protocol

Installation Qualification verifies components are placed and connected correctly.

Step 3

OQ Protocol

Operational Qualification tests the mechanical and control loops at active states.

Step 4

PQ Protocol

Performance Qualification ensures consistent, audit-ready sterile yields.

Interactive Compliance Inspector

Select an inspection checkpoint below to see how our Quality Desk verifies compliance parameter protocols:

Weld Integrity & Boroscopy

Process equipment for cleanrooms requires perfect weld joints to prevent microbial growth. We verify our welds using high-resolution video boroscopy.

100% video boroscope record of orbital weld joints.
Argon gas backing verification logs.
Certified ASME Section IX welding logs.

Ra Roughness Inspection

Surfaces must be electropolished or mechanically mirror-polished to prevent particle adhesion. We execute micro-roughness checks across multiple points.

Roughness profile mapping with calibrated profilometers.
Ra < 0.4 µm guarantee on all liquid-contact boundaries.
Passivation verification test records.

Pressure Vessel Testing

Process vessels, jacketed bioreactors, and heat exchangers are subjected to hydro-testing at 1.5 times the operating design parameters.

Jacketed and vessel chamber pressure tests for 24+ hours.
Dye penetrant weld examinations (DP test) to detect micro-cracks.
Pressure sensor calibration certificates.

GMP Documentation Suite

We compile a thorough technical folder with every unit shipped, containing material certificates, component details, and drawings for compliance audits.

Mill test certificates for SS-316L (EN 10204 3.1 certification).
FDA certificates for gaskets (EPDM, PTFE, Silicone seals).
Full trace record book with DQ, IQ, OQ testing sheets.