It is ABF olicy to deliver high quality cGMP-design in every aspect of the depyrogenation steriliser and to be in com­pliance with all major di­rectives within the pharma­ceutical industry.

We have specialized within the field of dry heat sterilizers for sterile production since the late twenties and can proudly say that the current design is a result of always trying to apply to the highest demands of our customers.

We understand production in sterile areas.
The DHS finds application for humidity sensitive materials such as glassware and metal containers that can be sterilized by steam sterilizers but cannot depyrogenate the load.At Neelam Industries, we assure the performance of DHS meeting the following specifications.

• STERILIZATION: Reduction of microbial spore forms up to 12logreduction.
• DE-PYROGENATION: Denaturing of microbial endotoxins in the material.

FEATURES :

• Neelam Industries depyrogenation steriliser are capable of performing up to 280 ° C, during the entire cycle. We have achieved this, due to our unique chamber construction and filter suspension system, and our never ending work for further improvements.
• High Temperature Hepa Filters High Temp HEPA filters are installed at inlet and exhaust side of the DHS. The HEPA-filters inside the chamber are equipped with full depth and height of chamber for suspension system solving the particle problem during heating and cooling.
• Chamber The Neelam Industries depyrogenation steriliser is made of stainless steel 316L. The chamber is fully welded inside, no leakage to the insulation can occur and the chamber is very easy to clean. The water cooling element is a continuous welded unit without any connections inside the cabinet boundary. It is pressure tested and is expected to last the lifetime of the steriliser.
• Door gasket As standard, Neelam Industries sterilizers are equipped with double door gaskets (FDA-approved). The purpose of dou­ble door gasket is to render maximum security, allowing no leakage between the chamber and the out­side.
• Further more the double gasket minimizes the surface temperature of the sterilizer, and any undesired air flow in the sterile area.
• Superior air control - Guarantee for complete sterilization Neelam Industries depyrogenation sterilisers operate in accordance with the forced convection principle with fast air circu­lation securing a rapid heat transmission to the load. Together with the shape and position of the electrical heating element, the calculated air distribution plates ensure a unique temperature distribution in the sterilization chamber. The temperature distribution is tested and fixed before delivery and does not require any adjustments in the life time of the steriliser, accordingly no down time for re-validation is needed. The uniform temperature in the chamber make it possible to fix the set-point temperature very close to the required minimum temperature for the sterilization.
• Program Cycle The cycle of a Neelam Industries steriliser is fully automatic.
• Drying The cycle starts with the drying phase where the damper on the exhaust is open ensuring, that any moisture will be removed from the chamber.
• Heating At a set-point temperature decided by the customer, the damper will close and the temperature will rise to the sterilizing set-point temperature. The damper will also stay closed during sterilization. Neelam Industries Sterlisers are equipped with a power-ful heating element to shorten the heating time
• Sterilizing The sterilizing timer can be started by the load sensors. The sterilizing timer will only be running if all the load sensors are within an acceptable range from the sterilizing set-point.
• Cooling If the cycle time is important, forced air cooling or water cooling is avail­able for rapid cooling in customized model.

Sizes available from 50 lts. to 4,000 lts.

AUTOMATION :

In compliance with :
cGMP, GAMP, ISO 9001 : 2008

Main applications :

• Glassware (Containers such as ampoules, vials etc.).
• Metal trays.
• Containers and metal material.
• Machine and accessories used in production.
• Various types of humidity sensitive material.