DS PH Series
Pharma Grade Parts and Glassware Washers.
DS PH – Pharma Grade Parts Washers are engineered and utilized for throughput, efficiency, and validatable cleaning and drying of various materials and components used in Biotechnology and Pharmaceutical Manufacturing processes, including laboratory glassware, filling line components, tools, tubing, TC fittings, valves and pump bodies, filter housings, reactor vessels, and miscellaneous equipment.
DS Series can be configured for different layouts and workflow requirements: single door or double door pass-through versions; with automatic motorized opening, vertical or horizontal sliding doors. Available also in hinged door version, full glass or stainless steel, to reduce footprint and ensure easy and safe access. Available in a wide range of chamber sizes, from 230 to 2,400 litres (8 to 85 cu ft), configurations and accessories to tailor each unit to the specific client requirements.
The design of the GMP range ensures self-cleaning of the chamber and pipework at each process stage, to prevent cross-contamination. Excellent cleaning and drying performance, combined with reduced process time and water consumption, characterize the DS series.
The heating elements, located in the sump, are pharma industry compliant, sanitary and dead leg free, fabricated from AISI 316L (1.4404) stainless steel and electro-polished. They may be connected to plant steam in the Steam heat exchanger version or directly to plant power in the Electrical heat exchanger version.
Steelco GMP washers are designed, manufactured, validated, and documented according to the latest global practices and standards to facilitate customer compliance with current Good Manufacturing Practices (cGMPs).
Reliable and Hygienic Construction
The washing chamber and the hydraulic system are designed and constructed with extreme care and have a surface finish with roughness average Ra<0.51 μm / 20μin (Ra<0.38 μm / 15μin available upon request). All wetted surfaces are crevice-free construction, with orbital welding for piping to eliminate water retention and stagnation points where biofilm could accumulate. AISI 316L stainless steel is used internally with EPDM, PTFE, or other FDA-approved (21CFR part 177) material gaskets. All models feature angled surfaces and rounded corners to ensure complete drainage. Detailed engineering on the sump reduces water consumption and assures high performance in terms of both cleaning and consumption. Multiple sanitary rotating washing arms are located on the top and on the bottom of the chamber to provide full washing and drying coverage for the items being processed, as well as the chamber.
Complete Layout Versatility
DS Series can be configured with different layouts: single door or double door pass-through version, offering sliding and hinged door models in various configurations: with an automatic motorized (vertically or horizontally) opening, in high-visibility full glass, or in stainless steel. The electrical cabinet and the drying system can be integrated within the skid of the unit or remotely installed. The technical area can be on the right or left side; alternatively, it can be shared in the case of “inline” installation of a pair of machines.
Steelco pharma-grade washers can run different cycle recipes, selectable from the operator panel. Each recipe is a combination of the following phases with adjustable setpoints and durations:
- Wash with or without detergent(s)
- Rinse with or without recirculation
- Recirculated, single-pass, or sequential final rinse
- In-between above steps, air purging of process piping is available to avoid any risk of cross-contamination
All standard or custom cycle recipes are analyzed and identified during the design phase, according to the items to be cleaned.
Effective Sampling Solutions
Sampling of process media is a key Quality Assurance requirement in any pharmaceutical cleaning process and cleaning validation procedure. Steelco offers a wide range of sampling systems to meet the most rigorous requirements:
- Water sampling from the sump
- Water sampling from final rinse system
- Water sampling from the point of use for each water
- Process compressed air line (PCA) sampling
- Clean steam sampling
For each sampling solution a T/C port, a manual or automatic valve can be installed in the technical service area or in an alcove on the machine fascia panel, according to client requirements.
Integrated Automation Architectures
Steelco provides a range of user-friendly control systems developed according to the latest ISPE GAMP© Guidelines and designed for FDA 21 CFR Part 11 and EU Annex 11 compliance. System platforms available include Siemens or Rockwell/Allen-Bradley. Irrespective of the platform, all Steelco Pharma equipment (washers, autoclaves, etc) has a common look and feel, consistent interface, and common GMP data management. Four levels are available, ranging from a local, standalone system to being fully integrated with the client IS infrastructure, in which the machine SCADA and related databases are hosted on the client network, providing the highest levels of data integrity and allowing in-house IT support and maintenance. Dependent on client policy, Steelco offers remote access via a virtual private network (VPN) to provide support during start-up, qualification, and maintenance activities.
Quality Engineering Process and Qualification Services
Technical consulting, design, engineering, project management, as well as commissioning and qualification services of our equipment are 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 with standard or customized protocols 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 and cycle development.
Customized Rack Configurations
Steelco designs, develops, manufactures, and tests its own racks and trolleys in-house, ensuring that this critical process’ quality attribute is assured and providing a single point of responsibility for the design and function of the entire cleaning process. Steelco’s engineering experience and sophisticated 3D CAD programs provide that every point, corner, and cavity of an item to be processed is deeply and efficiently cleaned, thus avoiding the possibility of cross-contamination and eliminating all soil and contaminant residues from the previous process. The same injection porting is used to also convey hot sterile filtered air inside each cavity for effective drying.
With more than 400 options and the widest range of chamber sizes available in the market, Steelco is able to meet the most challenging processing needs.
Thanks to a state-of-the-art hydraulic design, the device guarantees repeatable and validatable washing results with minimum water and energy consumption.
The drying unit enables variable drying temperature control, ensuring time reduction and excellent results. The HEPA filter is placed in line at the end of the drying path before entering the chamber and rack.
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.
Only proven, non-proprietary, globally available components and automation systems. Steelco provides full details of every component allowing customers to source spare parts either from Steelco or from the original equipment manufacturer.
The Innovative Cleaning Out of Place (COP)
Cleaning of tanks usually requires a large washer with high capital cost, utility consumption, and GMP floorspace footprint. Steelco has combined different cleaning requirements in one single, efficient, compact system that occupies minimal additional GMP floorspace than a standard parts washer.
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 230 litres / 8 cu ft
to 2.400 litres / 85 cu ft
Custom dimensions available upon request.
The overall dimensions may vary according to machine configuration and customer requirements. An electrical cabinet may be installed remotely from the machine. Air Handling Unit, as well as a detergent reservoir, may be installed remotely depending on space and operational requirements.