Product Details

GMP Component Washer

All areas of production in any pharmaceutical industry increasingly demand qualification and documentation of the cleaning processes. Years of experience with international customers has made Machinfabrik a reliable partner for validated cleaning. Our washers have been designed to meet and exceed the growing cGMP requirements of the Biopharmaceutical industry. Working in cooperation with users, our equipment has been developed to satisfy the unique demands and stringent regulations of the industry. We can provide a complete solution supported by need analysis and system design to suit your requirements.
Our systems are based on compatible modular units that can quickly be integrated and installed to form complete customized solution based solely on your needs. All machines are based on high-performance cleaning modules a rinsing system and an integrated air-drying system.

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Tech Specification

Injectable / Sterile Unit Washing Machine (ampoules / Vials / Rubber Stoppers Siliconization)

All MACHINFABRIK equipments are designed to comply with ASME Pressure Vessel codes, current GMP norms, EN 285, USFDA, EU, PIC etc. The system will be provided with DQ, IQ, OQ documents.

Cleaning procedures and efficacy of cleaning has become vitally important in the Pharmaceutical Industry. Poor cleaning, usually by manual process or with equipment’s not designed for the task can cause carryover of residue leading to subsequent batch / lot contamination. Machinfabrik GMP Component Washer fulfills the demands in this regard by satisfying various aspects related to decontamination and cleaning.

The GMP Component Washer is a batch type machine with pass through design.

The components and parts to be cleaned are loaded on mobile rack and pushed in to the chamber.

The cleaning process uses low pressure, high flow cleaning mechanism with water as the cleaning medium. The water is heated in a heat exchanger and is uniformly distributed by two rotating spray arms located at the top and bottom of the chamber for external cleaning and strategically placed nozzles on the rack for internal cleaning.

They system has facility to dose two type of cleaning agents using precision dosing pumps. After cleaning the components are dried using HEPA filtered hot air. The cleaning program is automatically controlled via a PLC and has the following sequence:-

Pre-cleaning.
Cleaning 1.
Cleaning 2.
Final rinsing.

The Cleaning Chamber is fabricated from SS316L and is completely welded without any joints. For easy cleaning all corners are rounded with a minimum radius of 25mm. All surfaces of the chamber has a slope > 3% to ensure full drain ability.

At the bottom of the Cleaning Chamber is a sump. The sump has sloping bottom to ensure there is no stagnation of debris and dirt during cleaning. The sump has a removable screen to ensure that small components, which are being cleaned to not accidentally, enter the cleaning circuit.

The Cleaning Chamber is provided with a lamp for illumination.

The Cleaning Chamber is provided with two Doors. The Door is fabricated from SS316L and has a toughened glass for visualizing the process. The Door is moved vertically with a pneumatic drive and is provided with an inflatable silicone seal.

The Cabinet Enclosure houses Cleaning Chamber, piping system, electrical systems and SS 304 facia panels of the unit. The Cabinet Enclosure is provided with service doors on the sides for maintenance and cleaning.

A cross-contamination seal is provided at the clean side for double door units to separate the clean and unclean sides. The system is designed to minimize the flow of the air from the clean area.

All process piping in contact with the chamber is fabricated from SS 316L with orbital welding. All connections and fittings used are sanitary tri-clamp with silicone seals.

The process valves in contact with the chamber have SS 316L contact parts with Teflon seat and tri-clamp connections. All other valves have threaded connections.

The GMP Component Washer is provided with a sanitary centrifugal pump with self-draining design. The pump body is of stainless steel for superior hygiene.

Two Dozing Systems are provided. Each Dozing System comprises of the suction lance, two level sensors for pre-empty and empty signal and a highly accurate dozing pump. The dozing pump is electronically controlled to ensure that the set quantity of chemical / detergent is dozed in the cleaning medium.

For heating the cleaning medium, water, a double tube sheet heat exchanger is provided in the circulation loop. For best results, the same Heat Exchanger is used for heating the air used for drying.

Different racks are provided for loading various components.

A SS 304 Floor Trolley is provided for easy loading and unloading of Racks.

The functioning of the washer is automatic and is controlled by a PLC. The PLC is operated with the help of a color, touch screen HMI with user-friendly features.

The PLC, instrumentation and electrical switchgear are housed in a SS304 panel installed on the skid.

The control cabinet is provided with a main isolator for the three-phase supply and a separate switch for the control supply.

For monitoring and controlling a RTD Pt100 Temperature Sensors, a Conductivity Sensor is provided in the Cleaning Chamber.

For on-line process recording a data printer is provided in the control panel.

For ease of operation and safety of the operator all critical and non-critical alarms are displayed on the HMI as a text message and audio signal is provided via an audio buzzer.
Optionally, the following features can be provided in the system based on URS:- CE Marking, UPS supply, utility isolation valves & gauges.