300 SERIES PHARMACEUTICAL GRADE WASHER

1) QUALITY and DESIGN

	Process tank
Model W300-100	Piping

The 300 Series pharmaceutical grade washers have been designed to meet the most stringent customer requirements and to comply with international standards with a view to providing high-level performance together with ease of access to components, all within a minimal footprint.

• The washing chamber entirely made of AISI316L grade mirror finished stainless steel, fully welded and finely polished to a surface finish of Ra ≤ 0,6 µm.
• All the water-wetted surfaces sloped to the drain.
• Rounded corners designed with a minimum radius R=20mm.
• No dirt traps
• No threaded components (screws and bolts) inside the washing chamber in compliance with GMP requirements.
• Up to four dosing pumps (compatible with detergent and caustic soda) for accurate chemical dispensing (concentration in the tank monitored by a conductivity probe).
• Pipework made of high-grade AISI316L stainless steel featuring standard 3-A sanitary fittings, tri-clamp connections, a fall to drain, absence of dead legs and orbital welding finely polished to a smooth finish.

2) WASHING SYSTEM

	Universal loading basket
Chamber	Quick-lock customized basket

The washing system was developed and engineered bearing in mind the high level of cleaning required in the pharmaceutical industry.

Rotating top and bottom spray arms ensure outstanding performances thanks to the balance between the quantity and pressure of the water-chemical solution.

Dedicated spray jets fitted directly on the racks are also provided to guarantee a perfect coverage of the load, especially for irregularly shaped components for which dedicated solutions can be engineered and tested at the factory prior to delivery to the site, all making for a superb wash result.

Washing, rinsing, and drying cycles make use of the same piping.

The final GMP rinse is provided by Water For Injection (WFI) injected directly into the piping. Software-hardware integration with the WFI loop is also available.

The high efficiency drying system, composed of a pre-filter, a fan and a HEPA filter (with EMRI testing connections) is provided to ensure not only perfect drying of the load, but also perfect drying of the piping and the washing chamber itself.

3) FLEXIBILITY

	Customized loading basket
Loading/unloading system	Large size flasks loading basket

The W300 Series is suitable for processing of a wide range of components, from small glass vials, all the way through to injectors, pumps, compressing tools, feeding hoppers and pallets.

Small plastic or stainless steel containers and hollow components are washed both outside and inside by means of special sprayballs. Unlimited washing solutions are available thanks to multipurpose, quick-lock racks built according to customer-specific needs. An ergonomic transport trolley facilitates loading and unloading operations and ensures smooth handling throughout the facility. Single or double panoramic glass doors allow visual monitoring of the process as well as installation through the barrier.

The double door configuration features interlocking doors and is suitable for pass-through applications thanks to a bio-seal type insulation provided on one or both sides.

Compressing tools	Valve
Dosing pump	Filling line component

4) RELIABILITY, MODULARITY and SAFETY

HMI touch screen
Clean side view	Model W300-025

The W300 Series comes as a modular machine available in 4 different sizes from 0.25 m³ up to 2.0 m³.

The cleaning process is micro-processor controlled offering fully programmable and customizable washing cycles with single or multiple detergents, rinse monitored by a conductivity probe on the drain, final GMP rinse, and drying to achieve the desired results.

The user-friendly multi-language touch screen HMI is a simple interface with all the critical parameters displayed in real time.

It may be connected to a printer or to a remote PC located in the supervisor’s office for data monitoring and recording.

The start cycle is inhibited if the door is not properly closed and cycle progress onto the next stage is disabled if process parameters fail to match the set point.

To guarantee operator safety, cool-down time is also foreseen to avoid any possible exposure to high temperatures.

5) LOW UTILITY CONSUMPTION

Ongoing research and development of new technologies, focusing on sustainable development, allows us to continuously reduce the environmental impact of both our washing machines and our production process.

Thanks to an innovative design we are able to constantly cut down energy, water and chemical consumption.

All of those principles also make for low running costs, shorterterm break-even points and return on investment.

It is with through philosophy that we build excellent washing machines with high performances, technologically advanced and
extremely safe for both operators and the environment.

6) VALIDATION and DOCUMENTATION

Electrical testing instruments	Temperature and pressure calibrating instruments	Riboflavin cleaning assesment

A risk-based approach to validation checks the regulatory compliance and ensures that the equipment works as designed, meeting user specifications with guaranteed performances and safety.

A full validation package includes Factory Acceptance Test (FAT) which takes place just after the production and the internal testing phase for your absolute peace of mind. Installation and start-up are followed by the Site Acceptance Test (SAT), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). These tests guarantee that both process and machine are effective and up to agreed user specifications.

All equipments come with a GMP compliant documentation package, including but not limited to:

• USER AND MAINTENANCE MANUAL
• INSTALLATION LAY-OUT
• ELECTRICAL DRAWING
• P&ID diagram
• Pneumatic drawing
• Main components technical data sheets
• Material certificates
• Welding certificates
• CE declaration form
• Validation protocols (IQ-OQ-PQ-FAT-SAT)
• Welding and Material certificates