07/07/2025
Not all sterilizers are built the same, and depending on your applications, the differences can be critical. From construction and components to compliance and documentation, there are key distinctions between laboratory-grade sterilizers and cGMP-compliant models. If you're not sure which one fits your needs, this quick guide can help clear things up:
🔨 1. Chamber Construction
cGMP: 316L stainless steel, 25 Ra finish or better, sloped to drain.
Lab: 316L stainless steel, minimum 50 Ra finish, not sloped to drain.
🔗 2. Piping & Connections
cGMP: 316L stainless steel, sloped to drain, no dead-legs, orbital welded or sanitary fittings.
Lab: Copper piping, not sloped to drain, threaded connections (BMT lab sterilizers are standard equipped with stainless steel piping).
🚪 3. Valves
cGMP: 316L stainless steel valves with sanitary connections.
Lab: Brass valves with threaded connections.
🌡️ 4. Temperature Control
cGMP: Dual chamber RTDs in drain (Control + Monitoring).
Lab: Single RTD (Control only).
🌀 5. Chamber Air Filter
cGMP: 0.2-micron filter, sanitary stainless housing.
Lab: 0.2-micron capsule filter.
💨 6. Air Removal System
cGMP: Vacuum pump required.
Lab: Water ejectors are acceptable.
💧 7. Steam Quality
cGMP: Clean or pure steam supply required.
Lab: Plant Steam to the chamber is acceptable.
🧠 8. Control Systems
cGMP: PLC control systems (Allen Bradley / Siemens)
Lab: Microprocessor controls (PLCs optional)
📄 9. Documentation
cGMP: Material & calibration certificates, IQ/OQ & PQ validation, FAT/SAT.
Lab: Certificates & validation not required, but recommended.
✅ 10. Compliance
cGMP: Full compliance with FDA requirements.
Lab: Designed for research, non-regulated use, or Biosafety Level requirements.
Whether you're designing a pharmaceutical production facility or upgrading your lab's sterilization capabilities, BMT USA offers sterilization solutions engineered for your environment, with quality, compliance, and reliability at the core of every unit. Contact us to discuss the right sterilizer for your facility or learn more about our equipment at https://bmtusa.com