Water Bath Sterilization Autoclave For Sterilize Prefilled Syringes

Description:

The working principle of Medpharm Super heated water spray autoclave is based on the

automatic counter pressure by injection of compressed air into the chamber during the entire

cycle to minimize the differential pressure across the containers generated by the exposure to heat.
 

Specifications:

   Design for installation on the floor (for loading with in-chamber & transfer trolley) or

   pit mounted (for loading at floor level with in/out trolleys or automatic loading/unloading units)

Single or double door with Sliding door options to suit client specific requirements.

Cylindrical single-wall chamber in highly finish 304 stainless steel.

Chamber pipings and fittings in 304 stainless steel, Tri-clover clamp connection.

Water spray distribution headers fitted with nozzle suitably located to assure water uniform

distribution on the product with consequent excellent temperature uniformity throughout the

entire load.

High efficiency plate type heat exchanger, in AISI 316L S.S., for recirculation of

heating / cooling water.

Pressure Monitoring inside the chamber by pressure transmitter.

Water level monitoring inside the chamber by sight level assembly and capacitive

level sensors.

The touch-screen for visual process control and connections for measuring signals

and printers.

Remote support connection as option.

Online Printing and recording confirming to 21 CFR PART 11.

0.2 bacteria retentive, sterile air filter for vacuum break.

Contamination Seal to prevent cross-flow of air between the clean and un-clean area.

Validation ports for insertion of temperature sensors for thermometric testing
 

Applications:

Sterilization of filled containers of HDPE/LDPE bottles, PVC multi-layer pouches or

glass bottles.

Competitive Advantage:

1. Using sanitary-type centrifugal pump, water from the bottom of the chamber will be circulated

through a heat exchanger.

2. After that water will be circulated into the upper part of the chamber and it will be distributed

on the load by a system of spray nozzles.
 

3. Water is maintained in liquid form at super heated temperature due to positive pressure

in the chamber and thereby efficiently sterilizes the load.
 

4. Positive pressure is maintained in the chamber that counterbalances pressure build up

in flexible containers thus preventing container bursting or deformation.