How is batch recording documented for regulatory release?

The Siemens PLC logs all temperature channels and door interlock events with electronic batch record generation.

What warranty applies to this machine?

Machines are supplied with a 12-month warranty from commissioning covering manufacturing defects, with wear parts and tooling excluded. Extended cover is available under an annual maintenance contract, which also fixes response times for breakdown attendance.

What documentation is supplied at handover?

Handover includes the operation and maintenance manual, electrical and pneumatic schematics, the spare parts list with part numbers, material test certificates for contact parts, sensor calibration certificates and the completed qualification dossier.

What water quality does the machine require?

Final rinse requires Water for Injection or Purified Water depending on the dosage form, supplied at the specified pressure and temperature. Earlier rinse stages can run on potable or purified water, and the machine records the conductivity of the final rinse.

How is cleaning effectiveness demonstrated?

Effectiveness is demonstrated during performance qualification by riboflavin coverage testing, followed by swab and rinse sampling against the residue limit calculated for your worst-case product.

What drainage is required at the installation point?

A floor drain sized for the peak discharge rate is required adjacent to the machine, with an air break to prevent back-siphonage. The utility schedule supplied with the machine gives the exact flow and connection sizes.

CDO-1500 Cleanroom Class 100 Forced Air Depyrogenation Oven

Name: CDO-1500 Cleanroom Class 100 Forced Air Depyrogenation Oven
Brand: GentlemanPharmed
Availability: InStock

Batch pass-through hot air sterilizing and depyrogenating oven (250°C to 300°C) with Class 100 HEPA air circulation across all thermal phases.

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Overview

About the CDO-1500 Cleanroom Class 100 Forced Air Depyrogenation Oven

The **CDO-1500 Depyrogenation Oven** is a pass-through batch dry-heat sterilizer designed for depyrogenating glass bottles, vials, stainless steel containers, and ampoules. Operating up to 300°C, the oven maintains continuous ISO Class 5 (Grade A) particulate cleanliness throughout heating, dwell, and cooling cycles via high-temperature ceramic-sealed HEPA filters.

Continuous Hot Class 100 Airflow: Specialized high-temperature HEPA filters withstand 300°C with zero silicone sealant outgassing.

Recorded Final Rinse Conductivity: Final rinse water quality is measured and written to the batch record, giving objective evidence that the cleaning cycle completed to specification.

Validated Cycle Recipes: Wash, rinse and dry stages run to stored recipes, so the qualified cycle is reproduced exactly on every load.

Specifications

Technical Specifications

Technical specifications for the CDO-1500 Cleanroom Class 100 Forced Air Depyrogenation Oven
Chamber Dimensions	1,200 mm (W) × 1,400 mm (H) × 900 mm (D)
Max Temperature	300°C
Heating Power	36 kW

* Specifications may vary by model. Contact us for exact configuration.

Validation Support

Full IQ/OQ/PQ documentation packages available. Our validation team works with your QA department to ensure regulatory acceptance.

Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Factory Acceptance Test (FAT)
Site Acceptance Test (SAT)

Compliance Standards

Built and tested to international pharmaceutical manufacturing standards.

WHO-GMPISO 9001CE MarkedCDSCO

FAQ

Product FAQs

Common questions about our pharmaceutical machinery.

CDO-1500 Cleanroom Class 100 Forced Air Depyrogenation Oven — Product Brochure

Technical specs, dimensions & ordering guide · PDF

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About the CDO-1500 Cleanroom Class 100 Forced Air Depyrogenation Oven

Chamber Dimensions

1,200 mm (W) × 1,400 mm (H) × 900 mm (D)

Max Temperature

300°C

Heating Power

36 kW