- Preheating: Preheating is an important process of a dry heat sterilizer. In this process oven is preheated to a high temperature, typically ranging from 250°C to 300°C to effectively destroy pyrogens.
- Loading: In this process, the materials including vials, ampoules, glassware, or other heat-resistant items are loaded into the oven. Usually movable trolley with trays are used in this process.
- Heat Exposure: The loaded items are exposed to the high temperature in the dry heat sterilizer for a specific duration. This duration is determined based on the nature of the material and the required level of depyrogenation.
- Uniform Heat Distribution: Uniformity of heat distribution is also important. A dry heat sterilizer is designed to ensure uniform heat distribution throughout the chamber. This helps to achieve consistent and thorough depyrogenation of all objects inside. During this process HEPA filters fitted in this oven help in removing particles from circulated air.
- Cool-Down Phase: After the specified depyrogenation time, the oven is turned off, and the items are allowed to cool down gradually. This helps to prevent thermal shock and potential damage to the objects.
- Monitoring: Throughout the depyrogenation process, temperature sensors and controllers monitor the oven's internal temperature to ensure it remains within the desired range.
- Validation and Documentation: The depyrogenation process is validated to ensure its effectiveness in removing pyrogens. This involves testing samples from the depyrogenated items to confirm the absence of pyrogens. Documentation of the process parameters, such as temperature, duration, and validation results, is important for regulatory compliance and quality control purposes.
Dry Heat Sterilizers designed for depyrogenation to make pharmaceutical products pyrogen free
Depyrogenation Oven
Depyrogenation Oven also called Dry Heat Sterilizer is widely used in pharmaceutical industries for dry heat sterilization of pharmaceutical products and components including penicillin bottles, ampoules, aluminum caps, tools and vials glassware etc. This process is often applied on heat-stable oils, ointments and powders and also on heat-stabile components, glassware and metal parts etc. in order to make final product pyrogen free. This process destroys both microbial and pyrogenic contaminants that may present on surface of the products.
A complete Depyrogenation process combines seven steps explained below:
We are depyrogenation oven or dry heat sterilizer manufacturers in India. Our dry heat sterilizers are available in standard sizes as well as customized in various sizes. Standard models come in 225, 640, 1200 and 1800 liters or more. For customized units, we need dimensions and quantity of the products to be depyrogenated. These dry heat sterilizers or Depyrogenation ovens are made in double doors (pass through type) for batch type process. Each unit is ruggedly constructed with stainless steel AISI 316 (contact parts). Chamber is easy to clean.
Contamination free air circulation is mandatory to depyrogenate products inside; therefore, our dry heat sterilizers are equipped with HEPA filter modules and pre-filters, filtered air is circulated through impeller into the chamber.
Standard temperature range of a depyrogenation oven is ambient +10°C to 300°C. Temperature is controlled through touch screen based microprocessor based controller. Our depyrogenation ovens are loaded with many necessary safety features. FDA 21 CFR is optional
Features & Benefits
- Perfect for class 100 applications
- Stainless steel inner construction
- Meet class 100 standard
- HEPA filtered air inlet
- Excellent door tightness
- Uniform temperature distribution
- Over temperature protection
Technical Specifications
| Model | STXDHS-1 | STXDHS-2 | STXDHS-3 | STXDHS-4 |
|---|---|---|---|---|
| Inner dimensions mm (W*D*H) | 600*500*750 | 800*800*1000 | 1000*1000*1200 | 1000*1200*1500 |
| Volume | 225 Liters | 640 Liters | 1200 Liters | 1800 Liters |
| Overall dimensions mm (W*D*H) | 1650*900*1750 | 1850*1200*1950 | 2050*1400*2150 | 2050*1600*2450 |
| Heating power kw | 9 | 15 | 22 | 28 |
| Circulation fan power | 1.1 KW | 2.2 KW | 3.0 KW | 4.0 KW |
| Fan power | 0.06 KW | 0.18 KW | 0.18 KW | 0.25 KW |
| Exhaust fan power | 0.18 KW | 0.25 KW | 0.37 KW | 0.75 KW |
| Design temperature range | RT to 300°C | RT to 300°C | RT to 300°C | RT to 300°C |
| Cleanliness level | 100 grade | 100 grade | 100 grade | 100 grade |
| Circulation fan air quantity | 2540 m3/h | 2700 m3/h | 2900 m3/h | 3200 m3/h |
| Fan air quantity | 300 m3/h | 408 m3/h | 408 m3/h | 408 m3/h |
