Analytical science
Raw-material qualification, fluid-bed parameter control, in-house analytical testing and scale-down formulation development sit in one system.
The quality group is split into Quality Control and Quality Assurance, working with Regulatory Affairs.
Quality Control runs the instrumentation laboratory and wet suites: raw-material assays, in-process checks, finished-pellet release and stability monitoring.
Quality Assurance holds release authority. It audits batch manufacturing records, supervises line clearance, manages change control, qualifies vendors and qualifies equipment.
Quality department
Managing Director / technical technocrat
Manager — QC
4 chemists / analysts
Manager — QA
4 QA officers
Eight-person quality team spanning three shifts.
QC laboratory
Quantitative assays, chromatographic impurity profiling and USP dissolution kinetics, performed in-house.
Quaternary Gradient HPLC System with UV/VIS Detector
Automated autosampler, column thermostat, multi-wavelength UV detection, and chromatographic data management software.
Quantitative assay of active pharmaceutical ingredients, related substances, organic impurities, and blend uniformity analysis.
Automated 8-Station USP Apparatus 1 (Basket) & Apparatus 2 (Paddle)
Digital microprocessor speed control (25–250 RPM), motorized lift mechanism, and precision water bath temperature control (+/- 0.1°C).
In-vitro drug release profiling for IR, EC (acid-stage to buffer-stage transition), and 24-hour SR multiparticulate formulations.
High-Resolution Double Beam Spectrophotometer
Wavelength range 190–1100 nm, 1 nm spectral bandwidth, automated wavelength calibration, and photometric accuracy.
Routine quantitative drug release testing, single-point concentration measurement, and active substance identification.
Dual-Range Micro Analytical Balance
Readability down to 0.1 mg / 0.01 mg with internal automated motorized calibration and draft shield enclosure.
High-precision weighing of reference standards, sample preparations, and assay aliquots.
Volumetric Karl Fischer moisture titrator with automated titration end-point detection and drift compensation.
Accurate determination of trace water content and residual moisture in pellets, polymer films, and hygroscopic actives.
GMP Environmental Test Chambers
Microprocessor temperature and relative humidity monitoring with continuous data logging and multi-zone safety alarms.
ICH stability studies: Accelerated (40°C +/- 2°C / 75% RH +/- 5%), Long-term (30°C +/- 2°C / 65% RH +/- 5%), Zone IV A, and Zone IV B conditions.
Multi-point automatic buffer calibration, automatic temperature compensation (ATC), and precision glass electrode.
Accurate measurement of buffer solutions, mobile phases, and reconstituted dissolution media.
Direct micro-Siemens per cm (µS/cm) measurement with automatic temperature compensation.
Continuous monitoring of purified water conductivity across production generation and loop return lines.
Magnified optical viewing chamber with digital linear heating ramp controls.
Raw material identification and purity verification for incoming active substances and solid polymers.
Calibrated 3D vibrational sieving action with digital timer and amplitude regulation.
Determination of particle size distribution (PSD) and mesh fraction grading for sugar cores and finished coated pellets.
PID temperature regulated forced-air convection oven operating up to 250°C.
Loss on drying (LOD) testing and thermal conditioning of analytical glassware.
High-speed variable angle centrifuge and multi-frequency heated ultrasonic sonicator.
Rapid extraction and dissolution of active drugs from polymeric pellet matrices during analytical sample preparation.
Conducted through pre-qualified, cGMP/NABL-accredited contract analytical laboratories under formal Quality Technical Agreements, maintaining data integrity and audit-ready certificates of analysis.
Stability
Chambers hold temperature and relative humidity with failover and continuous electronic logging, for partners filing dossiers across climatic zones.
Purified water
Sanitary SS-316 storage, continuous recirculation, and automatic dump valves if conductivity leaves its limit.
01
Incoming pre-treated potable water is buffered and continuously fed into the demineralization train.
02
Effectively extracts dissolved metallic cations (Ca2+, Mg2+, Na+) and mineral anions (Cl-, SO4 2-, HCO3-).
03
Polishes remaining traces of ionic impurities to achieve purified water electrical conductivity meeting pharmacopoeial standards.
04
Inactivates microbial contaminants before water enters the storage loop.
05
Holds validated Purified Water under continuous recirculation loop to prevent microbial stagnation.
06
In the event of conductivity failure, water is automatically dumped in both generation line and return loop without contaminating the reservoir.
System qualification
These phases qualify the installed generation and recirculation system. They are not additional processing stages.
01
Operational parameter verification, sanitization cycle establishment, and intensive sampling across all system points.
02
Demonstration of consistent purified water quality following approved operating procedures.
03
Demonstration of long-term consistency and seasonal stability across continuous manufacturing operations.
Formulation R&D
Aashish Formulations bridges formulation science and commercial manufacturing through dedicated Formulation Research & Development (FR&D) suites equipped with scale-down simulation equipment.
The FR&D area is physically separate from commercial bays, so screening does not interrupt campaign schedules. A 3.0 kg coating pan, a 5.0 kg fluid bed coater and a 6-tray dryer are used to set atomisation, fluidisation and spray rate before transfer into the 500 kg commercial processors.
3.0 kg batch capacity
Initial formulation feasibility trials, starter core layering parameters, and binder screening.
5.0 kg batch capacity
Fluid bed parameter optimization, spray rate studies, atomization trials, and film thickness evaluation.
6 Trays pilot unit
Controlled moisture curing trials, residual solvent profiling, and loss on drying (LOD) parameter evaluation.
01
3.0 kg – 5.0 kg
R&D 18" Pan / 5 kg FBC / 6-Tray Dryer
Excipient compatibility & trial formulation
02
200 kg – 500 kg
200 kg / 300 kg / 500 kg FBCs
Process repeatability & batch release
QA and regulatory documentation can supply certificates of analysis, method summaries and Open Part Drug Master File packages.
