DS Optima PH – Compact-Size, Cost-Effective, Pre-Configured Full GMP Washing Machine

Steelco pharma grade machines comply with the applicable requirements of the following regulations and industry accepted guidelines:

  • cGMP
  • GAMP 5
  • FDA Regulation 21 CFR Part 11, 211, 820
  • Eudralex
  • PDA Technical Report
  • European and US Pharmacopeia
  • ISPE Guidelines
  • UL and CSA (on demand)

Chamber Volume
1200 liters / 43 cu ft

Chamber Dimensions WxDxH
1000 x 1000 x 1200 mm
40″ x 40″ x 48″

Overall Dimensions WxDxH
2200 x 1150 x 2500 mm
87″ x 45″ x 98″

Reliable and Hygienic Construction

The large 1200 liters washing chamber and the hydraulic system are designed and constructed with extreme care and have a surface finish with a roughness average of 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. The chamber features 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.

3 months, ready for FAT!

A fast-track development of a pre-configured fully GMP compliant washing machine for the pharmaceutical manufacturing industry. A compact-size, cost effective GMP washer with standard features and available options to enable minimal lead time from order to delivery.

Cycle Development

Steelco DS Optima PH can run different cycle recipes, selectable from the operator panel. Each recipe is a combination of the following phases with adjustable setpoints and durations:

  • Pre-wash
  • Wash with or without detergent(s)
  • Rinse with or without recirculation
  • Recirculated or single-pass
  • Drying
  • Cooling
  • 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.

Easy access to sampling and dosing system

A sampling of process media is a key Quality Assurance requirement in any pharmaceutical cleaning process and cleaning validation procedure. DS Optima PH can be equipped with different sampling systems provided of the manual or automatic valves to meet the most rigorous requirements:

  • Water sampling from the sump
  • Water sampling from the final rinse system
  • Water sampling from the point of use for each water

Easy access to the sampling system and chemical storage from the technical service area located below the chamber on the loading side.

Integrated Automation Architectures

Steelco DS Optima PH is equipped with a user-friendly control system 15" color touch screen HMI (on loading side) 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.) have a common look and feel, consistent interface, and common GMP data management. Dependent on client policy, Steelco offers remote access via a virtual private network (VPN) to provide support during start-up, qualification, and maintenance activities.

Customized Rack Configurations

Steelco designs, develops, manufactures, and tests its own racks and trolleys in-house, ensuring that this critical process's 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 ensure 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.