Specification:

     The Autoclave Sterilizer Machine shall have minimum of the following alarms and safety 

     features, but not limited to:
  High Temperature over shoot alarm
  Too long time to create vacuum
  Vacuum pump trip alarm
  Utility failure alarm

   During the sterilization period if the chamber temperature falls below the set temperature,

      the sterile hold period counting shall stop. The counter shall restart again once the set

      temperature is reached.
  All the motors shall be provided with overload relay.
 

Description:

1.Autoclave sterilizer machine is horizontal with sliding horizontal opening double door,

horizontal chamber type (rectangular chamber with smooth round corners and jacket)

with fully automated operating system.The entire construction including all components

shall be fully compliant with cGMP requirements.

2.Contamination seal

A stainless steel flush mounting shall be fitted between the sterilization chambers and the

sterile area   wall to avoid any cross flow of air between the sterile and non-sterile side.

3. Vacuum pump:
The sterilizer shall be provided with a water-ring type vacuum pump.

4. Steam condenser:
Vendor shall provide a steam condenser made of AISI 304 fitted in the exhaust/vacuum line to

condense the steam before entering the vacuum pump.

5.Validation port:
The chamber shall be provided with two validation ports with dummy & adaptor for insertion of

multiple temperature sensors (minimum upto 16 temperature sensors).
The equipment shall have a provision on the steam feeding pipe which allows the installation of

an appropriate device (Client’s scope) for the execution of steam quality tests (non condensable

gas test, superheated gas test and dryness test).

6.Air Intake Filter:
The sterilizer shall have a sterilizing grade hydrophobic air intake filter of 0.02micron pore size for

vacuum break. The air intake filter shall be placed on the sterile side of the sterilizer. Option shall

be provided to sterilize the filter and perform integrity check. Relevant RTD for process control

and monitoring inside the filter housing shall be provided.

Applications:

The Autoclave sterilizer Machine shall be suitable for handling the following materials:
    Glassware
    Metal Trays
Containers and metal materials
Machine and accessories used in production
Basic biopharmaceutical products which can withstand heat treatment at high temperatures.
Clean room Garments
Lab Fermentors/Bio-Reactors
Silicon braided tubes etc.

Competitive Advantage:

Minimum sterilization requirements selectable as minimum F0 target.
Sterilization control selectable on time basis (with or without F(T,Z) calculation) or F(T,Z) basis.