INDUSTRY 04

Pharma / Biotech

04 / PHARMA

GMP-grade sanitary wetted parts for fermentation & crystallization.

8 applicable products 3 application cases

Overview

Pharmaceutical and biotech production has the strictest demands on online density / concentration measurement: hygienic wetted design, GMP compliance, CIP/SIP cleanability, full traceability. From fermenters through crystallizers to dosing tanks and purified-water systems, density is a key validation parameter.

Typical challenges

  • Sanitary wetted parts: 316L mirror polish, Tri-Clamp connections
  • CIP/SIP cleaning at 130°C for extended cycles
  • Small-batch, multi-product operations require quick re-calibration
  • 21 CFR Part 11 and GMP data integrity
Spectroscopic concentration meter · PS7100

Online Monitoring Solution for Methanol–Water Binary System

At the outlet pipeline of the circulation pump in the methanol distillation unit, the customer faced high risks of personnel exposure during manual sampling, a 2–3 hour delay in laboratory analysis, and an inability to adjust the water content in real time. The PS7100 explosion-proof spectral concentration meter was installed in a bypass flow cell, enabling simultaneous online monitoring of methanol and water content via near-infrared characteristic wavelengths, delivering sub-second response, non-contact measurement, and real-time DCS feedback.

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Spectroscopic concentration meter · PS7100

HF + H₂SO₄ + H₃PO₄ + DI Water Simultaneous Monitoring of Multi-Component Tank Solution Concentrations

Semiconductor 12-inch wafer foundries face challenges in BHF and SPM etching tanks: the concentrations of the four components—HF, H₂SO₄, H₃PO₄, and DI water—are prone to drift, making real-time monitoring difficult; manual sampling is both hazardous and time‑lagged; and reliance on empirical judgment for tank‑change timing leads to chemical waste or yield degradation. The PS7100 spectral‑based concentration meter, equipped with a PFA‑lined flow cell and sapphire optical windows, delivers online, synchronous concentration measurements for all four components, enabling sub‑second feedback and precise management of bath life.

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Spectroscopic concentration meter · PS7100

Multicomponent online analysis of substrate + byproduct + biomass + target product

During biopharmaceutical fermentation, customers face challenges such as infrequent offline sampling, high contamination risks, and the need for multiple sets of equipment to analyze multiple components, resulting in prolonged fermentation cycles and fluctuating product yields. The PS7100 spectral concentration/density meter enables online monitoring across the UV–Vis–NIR full spectrum, allowing a single instrument to simultaneously quantify glucose, ethanol, biomass, the target product, and byproducts. Compatible with CIP/SIP sterilization, it delivers sterile, continuous, real-time multivariate analysis.

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Selection support for this industry

Guides

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Industry FAQ

Can Pisonics meters be used in pharma GMP / FDA validation?

Yes. Pisonics offers GMP-compliant versions for the pharmaceutical industry:

  1. Wetted materials—316L electropolished, PTFE, and sapphire;
  2. Process connections—sanitary Tri-Clamp clamps (DIN 32676 / ISO 2852);
  3. Surface finish—Ra ≤ 0.4 μm mirror polish;
  4. Validation documentation—IQ/OQ validation documents, material traceability certificates (EN 10204 3.1), and surface roughness reports are provided upon shipment;
  5. CIP/SIP compatibility—withstanding steam sterilization at 134°C.

Typical applications: sugar/alcohol concentration in fermenter external circulation lines (PS7110 refractive index), concentration during injection solution preparation (PS7210 Coriolis), API crystallization (PS7300 differential pressure), and PAT process analysis (PS7100 spectroscopy). It has also passed a 21 CFR Part 11 audit.

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