Model No : DO-35
3-5 Working Days
Replacement
3 Days Replacement as standard, Free of Cost
Dedicated Support
Support from 9:30 AM to 6:00 PM everyday
The **Depyrogenation Oven** is indispensable in the pharmaceutical and medical device industries. Its primary significance is the **destruction of bacterial endotoxins (pyrogens)**, which cannot be eliminated by standard moist heat sterilization (autoclaving). Pyrogens must be reduced to extremely low levels (typically below 0.25 Endotoxin Units per mL) in products administered intravenously. This is achieved using **dry heat** at very high temperatures (typically $250^\circ\text{C}$ to $300^\circ\text{C}$) over a defined time, ensuring the product's safety and GMP compliance for manufacturing units in **Baddi, Hyderabad, and Ahmedabad**.
The key application is the **sterilization and depyrogenation of glassware and heat-stable equipment** used in aseptic filling lines, such as vials, ampoules, metal instruments, and processing components. Depyrogenation is a critical step before filling injectable drug products, vaccines, or large-volume parenterals (LVPs). The oven provides precise control over the high temperatures required to achieve the necessary 3-log reduction in endotoxin levels.
Employed by **Injectable Drug Manufacturers**, **Sterile Packaging Suppliers**, and **Compounding Pharmacies** across India, particularly in regulated markets like **Maharashtra, Tamil Nadu, and Karnataka**. It is also utilized in research settings where media preparation or instrument components must be absolutely pyrogen-free for sensitive cell culture or analytical work.
**Temperature:** Minimum $250^\circ\text{C}$ for Endotoxin destruction.
**Mechanism:** Dry heat oxidation and lysis of the endotoxin molecules.
**Validation:** Requires Thermal Mapping and Endotoxin Challenge Vials (ECVs).
**Requirement:** Essential for all final containers used for parenteral products.
**SEO Focus:** GMP Depyrogenation, Endotoxin Destruction, Dry Heat Sterilization.
Medico's **Depyrogenation Ovens** are engineered for extreme temperature capability and sterile environment maintenance. They feature heavy-gauge stainless steel construction, thick ceramic fiber insulation, and specialized high-temperature heating elements. Crucially, the oven must achieve and maintain outstanding **thermal uniformity** (often $\pm 5^\circ\text{C}$ at $250^\circ\text{C}$) to ensure all components receive the necessary heat dose to achieve the required **F-p value** for endotoxin destruction.
These units utilize **high-volume forced-air circulation** to rapidly reach setpoint and ensure heat distribution. For enhanced compliance and cleanroom integration, the oven often features a **double-door pass-through design**, allowing loading from a non-sterile area and unloading into a sterile area. This clean design and rigorous temperature control make it the gold standard for high-level sterilization in pharmaceutical production lines in **Goa and Himachal Pradesh**.
According to regulatory guidelines, the general rule is to maintain a temperature of at least $250^\circ\text{C}$ for a minimum duration of 30 minutes to achieve the required 3-log reduction of endotoxin (D-value).
Pyrogens (endotoxins) are fragments of bacterial cell walls that are highly heat-resistant. Moist heat (autoclaving) effectively kills bacteria but is insufficient to break down the stable lipopolysaccharide structure of the endotoxin. Only intense **dry heat oxidation** works reliably.
The **F-p value** (pyrogen reduction factor) is a calculated thermal lethality value, similar to F0 for sterilization. It represents the total thermal dose received by the load. Regulated industries must validate that the oven delivers a specific minimum F-p value to guarantee pyrogen destruction.
Yes. Although depyrogenation is its primary role, the high-temperature capabilities also mean it functions as an excellent **dry heat sterilizer** for any heat-stable item, killing all microbial life (spores, bacteria) via oxidation, in addition to destroying endotoxins.
We will send you an email to reset your password
We use cookies to improve your experience on our website. By browsing this website, you agree to our use of cookies
Your cart is currently empty.
Continue shopping
