Neelam Industries ISO
CLASS 5 continuous sterilizer is a fully automated system which utilizes dry
heat by means of forced convection of filtered air, through high efficiency
particulate air filter to achieve sterilization and depyrogenation of washed
empty pharmaceutical glassware used of parenteral product packing.
Neelam Industries continuous dry heat sterilizer ensures the glassware to
exposed for depyrogenation temperature. The time required for the necessary
reduction in endotoxins which at bare minimum is > LOG 3 at rated output.
The Sterilization Depyrogenation cycle is based on selection of cycle times
and exposure of temperature that will sterilize or depyrogenate the
glassware to an acceptable low probability level of contamination, without
adversely affecting the critical parameters of the product.
The Forced Conventional Dry Sterilizer consists of Drying Zone to raise the
temperature of the glassware and evaporate the wash water from the
glassware. The Sterilizing Zone sterilize the glassware at 300 °C and
the third section consist of cooling & sterilizing zone to restore the
glassware temperature to ambient.
Drying / Pre-Heat Zone II
Drying / Pre-Heat Zone Comprises of
Sterilizing Zone II
- SS 316 Module containing
- EU -7 grade Pre filter.
- Motor Blower assembly.
- EU 13 grade Minipleat Filter utilizing state - of art hot melt
- Mechanical differential pressure gauge to monitor pressure drop
across Final filter with respect to ambient.
- Proximity sensors, provided at in feed for dictation of
vials/ampoules overload, and interlocked with START/STOP of conveyor
- Integrated PT 100 temperature sensor to monitor temperature in the
Sterilizing Zone Comprises of
Cooliing / Stabilizing Zone II
- Double wall asbestos free ceramic wool insulated re circulatory
module containing high temperature EU - 13 grade final HEPA filter with
suck back mechanism suitable for 300 °C continuous repeated cycle.
- This zone provides uniform hot air over the glassware for the Purpose
of de pyrogenation. In this zone the temperature raises as quickly as
Possible by the help of heating element, without inducing cracking due
to excessive thermal stress. The glassware remains in this zone at a
required time period to meet The specified endotoxins reduction
generally > 3 log scale.
- This section consist of unidirectional hot air flow unit with turbine
blower assembly, High temperature HEPA filter (up to 350 °C) and
heater bank assembly.
- Integrated temperature sensors are provided for monitoring &
controlling purpose of Temperature inside the sterilizing zone. For this
purpose one sensor is placed above The HEPA filter and the sensor is
placed at the entry side of sterilizing zone. For Extra precaution one
temperature sensor provided at Heater Assembly ( 375 °C) is placed
for protection of Heaters.
- The entry and exit side of the sterilizing zone consists of manually
adjustable profile Plates resulting in maximum temperature uniformity
and ensure consistent result for Glassware with varying sizes.
- Differential Pressure gauge installed to monitor pressure Drop across
SS 304 Module Containing
- EU - 7 grade Pre filter.
- Motor Blower assembly.
- EU - 13 grade Minipleat Filter utilizing state- of - art hot melt
- Integrated PT 100 temperature sensor provided to monitor temperature
In the specified zone.
- Differential pressure gauge installed to monitor pressure drop across
- Extract blowers, provided underneath conveyor for cooling and
stabilizing zone with Discharge duct which is integrated with vapour
extract exhaust duct from Drying / Pre Heat Zone.
Vials/ampoules are subjected to significant thermal stress as they move
from sterilizing zone to cooling zone which may cause cracking or impulsion.
The air flow is profiled in such a way that the glass temperature as it
exits sterilizing zone would be transitioned in a linear way.
In compliance with :
cGMP, GAMP, ISO 9001 : 2008
Main applications :
- For sterilization & depyrogenating Glassware (Containers such as
ampoules, vials etc.).