GMP-Certified SS316L Vacuum Concentrator Pharma

Product Overview

GMP-Certified SS316L Vacuum Concentrator Pharma is a premium concentration system exclusively engineered for pharmaceutical manufacturing, with full GMP certification to meet the strictest regulatory requirements for drug production. Constructed entirely from SS316L stainless steel (wetted and non-wetted parts in contact with pharmaceuticals), it features an electropolished surface finish of Ra < 0.2 μm—exceeding standard GMP requirements—to minimize bacterial adhesion and ensure easy cleaning. The vacuum system enables low-temperature concentration (35–65°C), protecting heat-sensitive APIs and biological products from degradation. Key performance metrics include a working vacuum range of -0.095 to -0.099 MPa, a concentration ratio of 1:2 to 1:25, and a processing capacity of 20–500 L/batch. It comes with complete GMP documentation (including validation protocols, material certificates, and traceability records) to support pharmaceutical regulatory audits (e.g., FDA, EMA, NMPA).

Product Features

• Full GMP Compliance: Every component meets GMP Annex 1 (2022) requirements for aseptic processing; the system includes a closed-loop design to prevent air contamination, and all wetted parts are traceable via batch numbers (material certificates per EN 10204 3.1).

• Ultra-Low Temperature Concentration: The high-efficiency vacuum pump (oil-free, dry screw type) and a triple-stage condenser (heat exchange area: 2–10 m²) enable concentration at temperatures as low as 35°C, preserving >98% of API activity for thermally labile drugs (e.g., peptides, vaccines).

• Advanced Automation & Monitoring: A Siemens or Allen-Bradley PLC with a 10-inch HMI controls all process parameters (temperature, vacuum, agitation speed) and logs data in real time (21 CFR Part 11 compliant). Remote monitoring via SCADA is available for centralized process management.

• Aseptic CIP/SIP Functionality: The built-in CIP system uses pH-monitored cleaning solutions (0.5–2% sodium hydroxide/citric acid) with 360° spray coverage, while the SIP function (121°C saturated steam for 45 minutes) achieves a sterility assurance level (SAL) of 10⁻⁶, meeting USP <1221> standards.

• Minimal Product Loss: The conical-bottom tank design and low-speed PTFE scraper agitator (5–25 rpm) reduce product residue to <0.1% per batch, minimizing API waste and ensuring accurate batch-to-batch consistency (RSD <1% for concentration results).

Applications

• Injectable Drug Production: Concentrates API solutions for parenteral drugs (e.g., intravenous injections, subcutaneous injections) at 40–50°C to meet USP <788> particulate matter and <85> density standards.

• Biopharmaceutical Manufacturing: Processes biological products (e.g., monoclonal antibodies, recombinant proteins) at 35–45°C with minimal shear force, preserving protein structure and bioactivity (e.g., maintaining antibody binding affinity >95%).

• Sterile Oral Drug Production: Concentrates sterile oral solutions (e.g., pediatric drugs, ophthalmic solutions) to the required concentration, ensuring no microbial contamination (total viable count <1 CFU/mL) via SIP sterilization.

• API Bulk Production: Reduces solvent volume in API synthesis streams (e.g., after crystallization) to increase API concentration from 5–10% to 50–70%, simplifying downstream drying processes (e.g., lyophilization).

FAQ

Q1: What GMP certifications does the concentrator hold?

A1: It holds GMP certification from accredited bodies (e.g., SGS, BV) and complies with global pharmacopeias (USP, EP, JP). We provide a GMP Compliance Certificate, along with documentation of all GMP-related tests (e.g., surface finish, leak tightness).

Q2: Can it handle toxic or potent APIs?

A2: Yes. The system can be equipped with a contained design (closed transfer ports, HEPA-filtered exhaust) to prevent operator exposure to toxic APIs, meeting OSHA PEL (Permissible Exposure Limit) requirements for potent pharmaceutical ingredients.

Q3: What is the typical validation timeline for this concentrator?

A3: The Validation Package (IQ/OQ/PQ) can be completed in 4–6 weeks with our technical support team. We also offer on-site validation assistance to ensure compliance with local regulatory requirements (e.g., FDA inspection readiness).

1. Alcohol reclamation: Large reclamation capacity and the vacuum conc-entration procedure make it's production capacity five to ten times of that of the old counterpart and can lower the energy consumption for 30% , featuring little investment and high reclamation profit.

2. cocentrated liquid material: The device uses the modes of outer heated natural cycle and vacuum negative pressure evaporation featuring swift eva-poration with concentration proportion of 1.

3. The liquid material concentrates without bubble under full seal state. The drug liquid after concentration by the device features non-contamination and thick drug taste and easy cleaning(it is just to open the up and down cover for cleaning. ) The device is easy to handle and it needs a little foundation area for installation. The heater and evaporator use stainless steel for thermal purpose. The polyurethane is used as the thermal material. The surface is treated with sand grinding and surface polishing , meeting with the GMP Standard.