Pharma Grade Depyrogenation Ovens
Steelco designs and manufactures a wide range of Class 100 static depyrogenation sterilizers (ISO 14644-1 class 5) to meet the most challenging pharmaceutical requirements. The SD series is used to sterilize and depyrogenate of heat resistant materials, including bottles, vials, glass containers, metal trays, and production equipment, laboratory glassware and instruments, materials sensitive to humidity, thermostable basic pharmaceutical products, chemical compounds, and non-aqueous liquid materials such as oils, glycerine, etc.
The depyrogenation process aims to reduce the level of pyrogens, with the use of hot air in temperature which ranges from 220°C up to 280°C for a controlled period of time. The high-performance Class 100 oven solution ensures an even distribution of hot air for the entire cycle, including large loads, with the installed HEPA filters preventing cross-contamination.
Available in single or double door pass-through hinged door version, the devices feature chamber volumes from 330 to 10.000 liters (11.7 to 353 cu ft). On request and previous Steelco approval shall be possible to require customized chamber dimensions.
Steelco’s GMP depyrogenation ovens and dry heat sterilizers are designed, manufactured, validated, and documented according to the latest global practices and standards to facilitate customer compliance with current Good Manufacturing Practices (cGMPs).
Fully compatible with the strict standards of the pharmaceutical industry, the unit is provided with electrical heating elements and air recycling fan(s) positioned on top of the chamber. Pre-filters and HEPA filters are installed on the inlet and exhaust air ducts for preventing cross- contamination. The sterility of the air recycling in chamber is guaranteed by a set of HEPA filters installed in the air duct on the chamber side. Monitoring of chamber pressure and HEPA filters efficiency by differential pressure transmitters. Absolute filters’ housing provided with accessories necessary for the DOP test. The air cooling is carried out by an heat exchanger running by chilled or softened water.
Even Temperature Distribution
Differentially perforated walls, air speed and temperature control ensure an extremely air drying quality process. Tri-clamp connections for air quality monitoring and validation activities installed on fascia. As standard, one temperature product probe in chamber is provided for temperature monitoring. Upon request, additional temperature probes are provided.
Reliable and Hygienic Construction
Chamber, machine body, and aeraulic system made of AISI 316 stainless steel. Polish finish chamber with rectangular cross- section and rounded internal angles. Chamber bottom fitted with guides for moving the product holding carts. Fast-closing swing-out doors are equipped with an interlock system by pneumatic device that prevents the door to be opened during the cycle.
Integrated Automation Architectures
Steelco can install new equipment into an existing automation system by adopting a simple (HMI) or more sophisticated (SCADA) man-machine interface. User-friendly control systems developed according to the latest ISPE GAMP© Guidelines and designed for FDA 21 CFR Part 11, EU Annex 11 compliance. System platforms available include Siemens or Rockwell/Allen-Bradley, which are completely integrated with the client’s IS system and comprehensive network services such as integration with MES can be provided. In compliance with the individual internal policies of each customer, Steelco Group offers remote service access by using virtual private networks to ensure the confidentiality and safety of all transferred data.
Quality Engineering Process and Qualification Services
Technical consulting, design, engineering, project management, as well as commissioning and qualification services of our equipment is offered, with customers appreciating the cost effective high performance solutions offered to resolve complex washing and sterilization challenges. Design qualification (DQ), Installation qualification (IQ), Operational qualification (OQ), and Performance qualification (PQ) are provided in standard version or customized according to the final scope of supply. Customers are always welcome to visit Steelco factories to see design and manufacturing methods and audit our processes. Steelco Group is available anytime to support customers during all acceptance on site including process development and mapping.
The chamber and door(s) are externally insulated with high-density ceramic heat insulation and covered by AISI 304 stainless steel panels.
Hermetically sealed doors with a special-profile FDA certified silicone inflatable gasket.
External/Internal loading cart in AISI 316L stainless-steel, equipped with guides for shelves positioning.
Air Cooling System
The air cooling system inside the chamber is carried out by heat exchanger running by chilled or softened water. Water return system for recovery softner water loop available as option.
The on-board VPN router communicates on the local network with the PLC and the HMI, and allows remote connection from a computer, tablet, or smartphone without going on-site, drastically reducing support costs and improving machine uptime.
The machine is developed considering technicians’ access to the maintenance and service area – easy access to all components conforming to safety regulations.
Remote FAT service
In order to support the equipment verification procedures for our clients, we then introduce an alternative way to perform FAT – Factory Acceptance Testing, usually realized onsite. Remote FAT is a smart cloud-based service to support customers step by step in all procedures and testing and the production of related documentation that can be executed remotely, reducing the time required for staff to be away from the office and the associated costs including travel, accommodation, visa application, etc.
Steelco pharma grade machines comply with the applicable requirements of the following regulations and industry accepted guidelines:
- GAMP 5
- FDA Regulation 21 CFR Part 11, 211, 820
- ASME BPE
- PDA Technical Report
- European and US Pharmacopeia
- ISPE Guidelines
- UL and CSA (on demand)
from 330 litres / 11.7 cu ft
to 10.000 litres / 353 cu ft
Custom dimensions available upon request
The overall dimensions may vary according to machine configuration and customer’s requirements. Electrical cabinet may be installed remotely from the machine depending on space and operational requirements.