cGMP Pharmaceutical autoclave with fully automatic sliding doors designed to conform to end-user requirements (URS) using steam as the sterilizing agent, appropriate for pharma production and quality assurance processes. The 66120 autoclave chamber volume is 450 liters.
- cGMP Pharmaceutical Autoclave
- 450 Liter chamber volume
- PQ, FAT and SAT (IQ /OQ) optional
- Steam sterilizing agent
- Built to conform to end-user-requirements (URS)
Teknik Özellikler
Standart ✓ Opsiyonel o
Pressure Vessel | |
AISI 316L stainless steel chamber | ✓ |
ASME Code Section VIII, Division 1 or PED 97/23 EEC | ✓ |
AISI 316L stainless steel jacket | o |
Polished Surface (Ra less than 0.4 μm) | o |
Insulation encased in stainless steel | ✓ |
Jacket covering 100% of the chamber wall for uniform heat distribution. | ✓ |
Jacket cooling | o |
Bio-shield preperation | o |
AISI 304 or 316L stainless steel base frame | o |
Door(s) | |
Automatic sliding door(s) | ✓ |
Bi-directional door sequencing | o |
Piping & Components | |
Pharmaceutical grade sanitary piping and components (primary) | o |
Pharmaceutical grade sanitary piping and components (primary & secondary) | o |
PT100 temperature sensor in drain | ✓ |
Sanitary 0.2 μm air admission filter | o |
Chamber water level & alarm | ✓ |
Isolated pressure (membrane) gauges | o |
Videoboroscoping report for clean piping | o |
Air detector | o |
Other | |
Clean steam generator | o |
Biohazard system for waste treatment | o |
Filter integrity testing connections | o |
Autoclave Installation and Configuration
- Bi-Directional door sequencing controls on both sides of autoclave is standard on two door autoclaves
- Mounting can be recessed between two walls, in a wall, or stand alone
- Bio shield wall seal prevents airflow between different classified areas