Rapid Cooling Sterilizer - Operation & Features

By: Pharma Tips | Views: 5326 | Date: 07-Mar-2012

For terminal sterilization of specific products the conventional steam sterilization method is rendered ineffective as the load within an ampoule or a pouch is always subjected to the risk of deformation or destruction due to pressure imbalance wrt to the chamber pressure.The conventional autoclaves fail to provide the necessary pressure balancing for loads in sealed pouches or ampoules.


Introduction:

For terminal sterilization of specific products the conventional steam sterilization method is rendered ineffective as the load within an ampoule or a pouch is always subjected to the risk of deformation or destruction due to pressure imbalance wrt to the chamber pressure.
The conventional autoclaves fail to provide the necessary pressure balancing for loads in sealed pouches or ampoules. To overcome this drawback, Machinfabrik has conceptualized the rapid cooling autoclave. The exhaustive research at Machinfabrik resulted in not just successful pressure balancing for the enclosed product but A machine built to comply with all international regulations like ASME, USFDA, EN285, ISO and HTM 2010.the machine design is such that can adapt to a wide product range from glass ampoules, bottles or pvc pouches.

 

Rapid Cooling Sterilizer


Technique:

The constructional difference from a conventional autoclave is the design ensures automatic regulation of counter pressure using compressed air from a dedicate air reservoir. The over pressure not only accelerates steam evacuation from the chamber but also provides necessary counter pressure to ensure chamber integrity. After complete exhaust of the steam and marginal cooling of the load, an atomized water spray from a sprinkling manifold cools down the load.
The technique initiates with mechanical air removal from within the chamber utilizing a vacuum system followed by steam injection that comprises the sterilization cycle. The purpose of vacuum creation is to prevent any existence of air pockets that can hamper the steam penetration and hence the sterilization process.

Features:

At Machinfabrik our autoclaves are built to the highest level of quality assurance to meet custom defined requirements.

1.The machine design is in compliance to ASME sec viii .
The machine functionality in Compliance to the HTM2010 &EN285 standards accepted worldwide.
The control standards for the machine in compliance with the GAMP4

2.Assured cooling down load temperature to 60 deg.c in 6 minutes & +/- 0.5 deg.c temperature uniformity throughout the sterilization chamber. Baffle arrangement within the chamber to ensure uniform distribution of steam in the chamber.

3.The chamber if required can be provided with a skid framework & A flush mounted SS panel is provided on the sterile side to isolate it from the non sterile side.

4. PLC based control system for comprehensive automatic monitor and control of the process.

5.Safeties
Safety Valves for Chamber and Jacket.
Door Obstruction- the door will not open when the chamber is pressurized.
Both doors will not operate simultaneously to protect the integrity of sterile chain.
0.01 micron clean air filter for exhaust of the chamber from vacuum condition.

Applications:

Garments, machine parts ,machine accessories,containers.
Culture media,laboratory waste.
Bulk drugs.

Optional Features:

Steam Generator:

HPHV can be provided with an optional Steam Generator for independent and economic operation.
The Steam Generator is made of SS304/316 as per requirement. (36 kW)
Restricted upto a chamber size of 900 X 900 X 1200
SCADA(Supervisory Control and Data Acquisition):
Supervisory control and data acquisition system is a software that can be
operated with an desk top PC or a laptop.
The obvious advantage that a SCADA system offers as against the conventional
PLC-OPI system is remote monitoring and control over the entire system;along with a gamut of other facilities such as :

Continuous process status indication.
Mimic representation.
Meport generation of process performance
Trending facility
Online alarm facility
Alarm history facility
Increased security level
Recipe selection
SIP(Sterilization In Place):
We can provide the equipment with an additional cycle of "sterilization in place" of the clean air filter.
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