Pharmaceutical qualification

Pharmaceutical qualification

BECOMIX works in strict accordance with the latest pharmaceutical industry standards. All plants are qualified according to the guidelines:

  • ISPE
  • EU-GMP
  • GAMP for computer validation (CSV) of our automation

The CE-compliant documentation includes qualification for the

  • design (DQ)
  • installation (IQ)
  • operation (OQ)
Non-destructive material testing without disassembly of the components by means of X-ray fluorescence spectral analysis
Non-destructive material testing without disassembly of the components by means of X-ray fluorescence spectral analysis

We carry out the qualification measures for installation and operation together with our customers within the scope of the Factory Acceptance Test (FAT) and Site Acceptance Test (SAT).

Products

Applications

RW 250 CD: Production with sterile and toxic ingredients Sterile powder supply directly in the mixer

(Sterile) ointments

RW 600 CD with integrated homogeniser. 400 litre pre-phase. Inline metering. Transfer lines. CIP/SIP.

Nano-emulsions

LIM 400: Integrated turbo-dissolver and homogeniser in a single mixer. Heated direct transfer line to the filling line.

Suppositories

Main mixer RW 1.200 CD. PROMAS CS Basic. Semi-automatic control system.

Cough syrup

RW 600 CD with pre-phase MV 500 + MV 300. Fully automated and self-supporting CIP/SIP. Use of membrane valves for sterile processes

Ophthalmics

Main mixer RW 2.000 CD. Pre-phase MV 1.200. PROMAS CS Batch. Demineralised water dosing. Direct powder moistening below liquid level.

Suspensions

Main mixer RW 500 S. Sterile addition of raw materials. CIP/SIP. Atex zone 1.

Explosion prove zone 1. IQ/OQ. CFR 21 Part 11 software qualification. Recipe-guided control (PROMAS CS Batch). Total CIP.

Pharmaceutical creams

Main mixer RW 2.500 CD. Powder Jet technology. Recipe-guided control (PROMAS CS Batch). Automatic raw material dosing. CIP/SIP.

Pharmaceutical gels

Main mixer RW 2.000 S. pre-phase MV 400, MV 600. Inline raw material dosing. Inline process measurement. Sterile raw material supply.

Nose spray

Main mixer MV 2.500. Pre-phase MV 2,000. Inline raw material dosing, inline filling line.

Dispersions

Other technologies

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