gmp Standard Clean Steam Generator Bulk – Reliable Sterilisation for Pharma & Food Production
Product Overview
Our gmp standard clean steam generator bulk is engineered for continuous, high‑purity steam supply in regulated environments such as pharmaceutical manufacturing, food processing, and cosmetics production. The unit delivers saturated steam at temperatures up to 180 °C with <0.1 % total dissolved solids, ensuring compliance with GMP requirements while supporting bulk‑scale operations. Designed for easy integration, the generator can be mounted inline or as a stand‑alone system, providing a dependable steam source for sterilisation, cleaning, and process heating.
Industry Certifications & Safety
Every generator is manufactured in a certified ISO 9001 facility and conforms to EU GMP Annex 1, US FDA 21 CFR 211, and WHO guidelines for steam quality. The stainless‑steel heat‑exchange chamber (grade 316L) is passivated to prevent corrosion, and all pressure vessels are stamped according to PED/ASME standards. Built‑in safety interlocks, high‑limit thermostats, and automatic shut‑off valves protect both personnel and equipment, while a digital control panel logs temperature, pressure, and runtime for audit trails.
Typical Specifications (customizable per order)
| Parameter | Standard Range | Optional Upgrade |
|---|---|---|
| Steam Output | 5 – 150 kg/h | Up to 250 kg/h with dual‑drum design |
| Operating Pressure | 0.2 – 1.0 MPa | Custom pressure up to 1.5 MPa |
| Temperature Stability | ±2 °C | ±0.5 °C with advanced PID controller |
| Power Supply | 380‑415 V, 50/60 Hz | Single‑phase 220‑V option |
| Control Interface | LCD with local buttons | Modbus/TCP or Profibus communication |
*All specifications are indicative; engineering teams will tailor the unit to meet exact process requirements.*
Application Scenarios
- Pharmaceutical sterilisation: Provides validated steam for autoclaves, kettle‑cleaning loops, and aseptic filling lines.
- Food‑grade processing: Delivers low‑mineral steam for CIP (clean‑in‑place) cycles, reducing microbial load without chemical residues.
- Cosmetics & personal care: Enables continuous steam‑based cleaning of mixing vessels, ensuring product integrity.
- Laboratory & pilot plants: Scalable output supports batch‑size flexibility while maintaining GMP‑grade water quality.
Competitive Advantages
- GMP‑ready out of the box: No retro‑fitting required to meet regulatory steam purity.
- Energy‑efficient design: Condensing heat recovery can cut fuel consumption by up to 20 % compared with conventional boilers.
- Modular scalability: Units can be linked in parallel for seamless capacity expansion.
- Rapid commissioning: Pre‑tested factory units are shipped with detailed start‑up documentation, typically operational within 48 hours of delivery.
- OEM/ODM flexibility: We offer custom enclosures, branding, and integration of proprietary control software.
FAQ
What is the minimum order quantity (MOQ) for bulk units?
Our standard MOQ is one fully configured generator. For large‑scale projects, we can negotiate volume discounts and staggered delivery schedules.
Can the steam generator be customized for specific GMP requirements?
Yes. Our engineering team works with you to adjust materials, pressure ratings, control interfaces, and documentation to align with any regional GMP or ISO standards you must meet.
What is the typical lead time?
Standard models ship within 15‑45 days after order confirmation, depending on capacity and optional features. Customized designs may require 60‑90 days.
What warranty and after‑sales support are provided?
All units come with a 24‑month comprehensive warranty covering parts and labour. We also offer on‑site commissioning, training, and a 24/7 technical hotline for rapid troubleshooting.
Ready to secure a compliant, high‑performance steam solution for your bulk processes?
Contact Our Engineering Team Today