Pure Steam Generator for Pharmaceutical Industry Wholesale
Application Scenarios
In sterile drug manufacturing, any contaminant in the water‑steam circuit can compromise product safety. Our pure steam generator delivers 100 % condensate‑free, chemically inert steam that meets the stringent microbial and particulate limits required for:
- Sterilization of process vessels, heat exchangers, and CIP (Clean‑In‑Place) systems.
- Steam‑assisted drying of powders, granules, and lyophilized products.
- In‑line steam heating for reactors, mixers, and filtration units.
- GMP‑compliant environmental cleaning of clean‑room surfaces.
Because the unit is supplied wholesale, distributors can stock a range of capacities (from 5 kg/h to 250 kg/h) and offer immediate delivery to OEMs, contract manufacturers, and large‑scale pharma parks.
Product Overview
The pure steam generator for pharmaceutical industry wholesale is engineered to produce dry, high‑purity steam directly from de‑ionised water without the need for a separate boiler‑drum assembly. The system integrates a high‑efficiency heat‑exchange module, a compact condensate‑drain loop, and a built‑in steam‑quality monitoring sensor. Designed for continuous duty cycles (up to 24 h/day) and easy integration into existing PLC or DCS control architectures, the generator supports rapid start‑up (≤5 min) and precise temperature regulation (±1 °C).
Each unit is fabricated from 316L stainless steel, with all wetted parts meeting USP <659> and EP <3.1.3> requirements. The modular design simplifies on‑site installation, routine maintenance, and future capacity upgrades.
Technical Specifications
Below are the typical performance ranges. All parameters can be customized per order to match specific plant demands.
| Parameter | Typical Range | Unit |
|---|---|---|
| Steam Production Capacity | 5 – 250 | kg/h |
| Operating Pressure | 0.6 – 2.5 | MPa (gauge) |
| Steam Temperature | 120 – 180 | °C |
| Water Quality Requirement | 18.2 MΩ·cm (resistivity) | – |
| Duty Cycle | Continuous (≥90 % load) | – |
| Control Interface | Modbus/TCP, Profibus, or proprietary PLC | – |
Table: Typical Specifications (customizable per order)
Industry Certifications & Safety
Compliance is non‑negotiable in pharma production. Our generators are:
- Certified to ISO 13485 for medical device manufacturing support.
- Validated against USP <657> for steam purity (≤0.1 mg/L total non‑volatile residue).
- Conforming to IEC 61508 SIL 2 safety integrity level.
- Equipped with automatic over‑pressure and temperature shut‑off devices.
- Backed by CE marking for EU market entry.
All electrical components meet IEC 60335‑2‑81, and the hydraulic layout follows ASME BPVC Section VIII, ensuring seamless integration into regulated facilities.
FAQ
What is the minimum order quantity (MOQ) for wholesale purchases?
Our standard MOQ is one unit per capacity class. For bulk projects, we offer tiered pricing and can consolidate multiple capacities into a single shipment.
Can the steam generator be customized for a specific pharmaceutical application?
Yes. Options include additional filtration stages, enhanced condensate‑return loops, alternative control protocols, and bespoke panel layouts to match GMP‑validated processes.
What is the typical lead time for a wholesale order?
Lead time ranges from 15 to 45 days after final design approval and receipt of a purchase order, depending on capacity and required options.
Is there a warranty and after‑sales support?
All units carry a 24‑month limited warranty covering parts and workmanship. Our global service network provides on‑site commissioning, training, and a spare‑parts catalog with a 5‑year availability guarantee.
Ready to Equip Your Facility?
Contact our sales engineering team today to discuss capacity, compliance, and pricing for a pure steam generator for pharmaceutical industry wholesale. We’ll provide a tailored quotation and technical datasheet within 24 hours.
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