Dry Powder Sterile, Injection Sterile Plant, Large Volume Parental, Liquid Dosage, Pharma, Sterilization, WFI, utility, Washing, Filling, packing
Autoclave / steam sterilizer
Autoclave / steam sterilizer
Sterilization in simple terms, refers to any process that effectively kills or eliminates transmissible agents (such as bacteria, viruses, spore forms etc.) from a surface, equipment or biological culture medium. Sterilization can be achieved through application of heat, chemicals, irradiation, or filtration. Of these, heat (steam) sterilization is proven to be the most effective.
No living thing can survive direct exposure to saturated steam at 250 F (120 C) longer than 15 minutes. Hence death / destruction of microbial life is necessary to achieve sterilization. Steam, for a specified time at required temperature, must penetrate every fiber and reach every surface of items to be sterilized. When steam enters the sterilizer chamber under pressure, it condenses upon contact with cold items. This condensation liberates heat, simultaneously heating and wetting all items in the load, thereby providing the two requisites: moisture and heat.
There is exact demand of temperature /pressure control, process accuracy and documentation to adhere sterilization truly. Now based on the application demand, Steam Sterilizers are categorized mainly into four categories :
1. GRAVITY DISPLACEMENT STEAM STERILIZERS
Empty glass ware , utensils , vessels instruments & lab scale articles are best sterilized in these sterilizers. The technique uses the method of gravity air removal to ensure uniform steam distribution & penetration.
2. VACUUM STEAM STERILIZER
Porous material like garments, fabrics, machine & changed parts, bulk powders etc. are best sterilized in these Sterilizers. The technique uses mechanical air removal thru Vacuum pump & ensures 100% air removal which results in better temperature uniformity in the chamber. There is better steam penetration in porous products & vacuum drying at the end ensures drying of the material which was sterilized.
3. RAPID COOLING STERILIZER
Terminal sterilization of ampoules, glass bottles & sterilization of heat labile products are best achieved in these sterilzers. Here compressed air is used to create over pressure which accelerate steam evacuation from chamber & also provides counter pressure to ensure container / bottle integrity. Atomized water spray cools the load within chamber.
4. VACUUM TEST STERILIZER
Glass ampoules with fine line crack occurred during manufacturing , filling gets busted when exposed to vacuum du to high differential over wall.
Technical Specifications
| Description | 2x2x2 | 2x2x3 | 2x2x4 | 2x2x4 | 3x3x3 | 3x3x4 | 3x3x6 | 4x4x6 |
|---|---|---|---|---|---|---|---|---|
| Chamber volume – liter | 216 | 324 | 432 | 729 | 972 | 1458 | 2160 | 2592 |
| Chamber inside dimensions – mm | ||||||||
| Width | 600 | 600 | 600 | 900 | 900 | 900 | 900 | 1200 |
| Height | 600 | 600 | 600 | 900 | 900 | 900 | 900 | 1200 |
| Depth | 600 | 900 | 1200 | 900 | 1200 | 1800 | 2400 | 1800 |
| Overall dimensions – mm | ||||||||
| Width | 1050 | 1050 | 1050 | 1350 | 1350 | 1350 | 1350 | 1800 |
| Height | 1800 | 1800 | 1800 | 2100 | 2100 | 2100 | 2100 | 2400 |
| Depth | 1500 | 1800 | 2100 | 2100 | 2400 | 2700 | 3000 | 3300 |
| Pure steam | 51 | 76 | 114 | 149 | 197 | 295 | 395 | 486 |
| Peak load – kg/hr* | 3 | 3 | 4 | 5 | 5 | 7 | 9 | 10 |
| Pressure – kg/cm² | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 |
| Service Compressed air | ||||||||
| Peak load – CFM | 2 | 2 | 2 | 3 | 4 | 5 | 6 | 7 |
| Pressure – kg/cm² | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
| Vacuum pump | ||||||||
| Power – HP | 3 | 3 | 5 | 5 | 5 | 7.5 | 7.5 | 7.5 |
| Seal water flow rate – LPM | 5 | 5 | 5 | 6 | 6 | 7 | 8 | 10 |
| Seal water pressure – kg/cm² | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 |
| Maximum hardness – ppm | 125 | 125 | 125 | 125 | 125 | 125 | 125 | 125 |
| Total Power – kW | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 12 |
| DM water for rapid cooling | ||||||||
| Pressure – kg/cm² | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 |
| Flow rate – LPM | 32 | 96 | 144 | 192 | 256 | 320 | 368 | 392 |
| Air over pressure | 0.7 | 0.7 | 0.7 | 0.7 | 0.7 | 0.7 | 0.7 | 0.7 |
| Flow rate – LPM | 7.7 | 11 | 15 | 19 | 23 | 27 | 30 | 34 |
| Sterilizer empty weight – kg | 901 | 1125 | 1245 | 1315 | 1416 | 1695 | 2006 | 2277 |
| Door sliding to open facing from non sterile side | Right to left | |||||||
Construction Details
- Chamber is double walled with inner SS 316/SS 316L & outer in SS 304 with jacket in between
- Slopping bottom for condensate removal.
- Fully automatic horizontal sliding door and Hinged door with automatic locking
- A safety device prevents the operator from opening the door when chamber is pressurized
- Steam is not allowed into the chamber when the door is open
- A cycle will not start if the door is open or not properly closed
- The door cannot open until chamber pressure reaches room pressure
- Sliding Door Safety -The sliding door progress will automatically stop if an obstruction is detected
- Double Door Safety – interlocks prevent both doors from being opened simultaneously
Salient Features
- PLC validation as per 21CFRpart11
- Dimple jacket of SS 316 L provided for enhanced / uniform and temperature distribution (within ± 1° C during the sterilization phase.
- Multiple validation ports
- Bioseal : A biological safety barrier separates the sterile and non -sterile zone.
- Integration of sterile section with isolator
- Trays, carriage and floor trolleys provided.
- Pneumatically operated sliding doors with safety interlocks
- Dedicated after sales service with well trained technicians
Your Process. Our Precision.
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