GMP Washers for Small Parts (PDC).


For automated GMP, FDA compliant interior and exterior cleaning

Drums, lids, tension rings, seals
Small containers
Bottles, cans, hoppers
Barrels, horde plates, trays
Separators, filter housings
Filling line equipment, formatting parts
Pumps, dosing needles
Hoses, pipes, flanges
Tablet presses, rotors, punches and dies
Plastic materials
Laboratory glassware, pipets
Various utilities

 

 

  • Müller GMP washers allow flexible cleaning of all parts used in pharmaceutical production.
  • Innovative technologies lead to best-in-class efficiency and lower purified water consumption.
  • The state-of-the-art hygienic design offers the highest level of product safety.
  • Compliance with all the latest GMP requirements allows easy validation with a reliably reproducible cleaning and drying process.
  • Müller GMP washers are cleaning with recirculation, once through or using the water-saving pulsation rinsing process.
  • For flexible handling of different kinds of parts to clean with a broad variety of contaminations a high number of recipes can be programmed and saved within the control unit.
  • Müller provides cleaning solutions with tailor-made chamber sizes and individual system layouts for a variety of technical requirements.



Traits


Modular plant concepts for the most varied requirements enable flexible automated cleaning of practically all washable production goods in a GMP environment.

Müller has developed a unique modular plant concept for this purpose. It offers optimum solutions for a wide range of applications and specific requirements with regard to the wash goods, the spatial situation, the cleaning task, the necessary process steps, the required throughput, the available media and compliance with factory regulations.

MÜLLER Radial Sealing Technology = Easy replacement of seal
MÜLLER Clean Tank Design = Cutting-edge hygienic design
MÜLLER Flex Filling = Adjustable tank filling level
MÜLLER Hydro Coupling = Internal cleaning with higher water pressure
MÜLLER Clean Sensors = EHEDG compliant flush-to-wall installed sensors
MÜLLER Direct Dosing = Detergent dosing directly into media inlet pipe
MÜLLER Pulsation Rinsing = Final rinse with lower WFI consumption
MÜLLER Inline Heating = Heating & drying with flow heater
MÜLLER Thermal Disinfection = Prevents microbial growth
MÜLLER High Performance Drying = Fast drying due to reinforced blow-out using side channel blower
MÜLLER Dynamic Flow Chart = Process visualization (PID) at HMI

The size and quantity of the wash item determines the size of the washing chamber. The three standard sizes 800, 1200 and 1600 are available. Special chamber sizes can also be realized.

In order to meet individual installation situations, various design options are available for all Müller GMP washers:

  • one- or two-door operation; two-door also as a sluice system with airtight separation of classified clean rooms
  • vertical door opening for the smallest possible footprint with sufficient ceiling height
  • horizontal door opening for low ceiling heights
  • technical room arranged on the left or right
  • access to the plant room optionally from the loading side, from the side or from the ceiling via special plant room levels
  • sesigned as a wash isolator in the high-containment area: Equipment of the wash chamber with glove openings for unpacking contaminated wash items in the closed cleaning system and integration of an Alpha-Port-transfer system to discharge the contaminated packaging material; in addition, the washing chamber exhaust air is cleaned by a HEPA filter system with safe change filter change option.

Wash chamber
316L/1.4404, wash chamber surface mirror polished Ra ≤ 0.4 µm, weld seams polished Ra ≤ 0.4 µm

Piping
316L/1.4404, pipe quality class DIN ISO 11866-series B without visible longitudinal weld seams, inner surface Ra ≤ 0.4 µm, weld seams Ra ≤ 1.2 µm

Diaphragm valves
316L/1.4435, inner surface Ra ≤ 0.4 µm, pneumatically driven, optionally with position feedback

Sterile flange connections
316L/1.4404, DIN ISO 11864-3 form A, according to EHEDG (Hygienic Design), inner surface Ra ≤ 0.4 µm.

Wash pump
316L/1.4404 according to EHEDG (Hygienic Design), inner surface Ra ≤ 0.4 µm

Heat exchanger and auxiliary tanks
316L/1.4404, inner surface Ra ≤ 0.4 µm

  • all plastics in contact with the product FDA-approved
  • optional: all surfaces in contact with the product electropolished, Ra ≤ 0.6 µm
  • optional: all surfaces in contact with the product in material 316L/1.4435 and delta ferrite content ≤ 3

Plant cladding
304/1.4301, finely ground Grain 320, Ra ≤ 1.0 µm

Transfer carriage for the transport of washload carriers
304/1.4301, electropolished, optionally with drip pan and drain cock

  • optional: additional claddings for connection to cleanroom walls or ceilings and floor trays with and without drainage for building protection in case of leakages

Dosage

  • addition of cleaning agents via stroke-monitored diaphragm dosing pumps and suction lances
  • optional: dosing directly from the on-site supply line
  • optional: dosing monitoring via impeller counter, flow meters or conductivity measurement

Sensors

  • choice of pressure, temperature, flow, conductivity and TOC sensors from various proven manufacturers

Heating and drying

  • optional water heating and drying air heating with steam or electrically

Wastewater

  • optional: additional, recipe-controlled outlet for contaminated waste water
  • optional: waste water pump in the absence of waste water gradient
  • optional: waste water cooling for hot waste water

Exhaust air

  • depending on the on-site exhaust air extraction, optionally with draft breaker, exhaust air damper or exhaust air cooler for fume condensation

Operation

  • 12'' touch panel with high-resolution TFT colour display on the loading side, in case of two-door cleaning systems additionally on the unloading side 7'' touch panel with TFT colour display
  • optional: for more complex applications, larger 15" or 19" touch panels can be selected

Müller pharmaceutical cleaning systems are based on the latest state of the art in pharmaceutical technology and hygienic design and therefore meet in particular all current requirements and specifications for pharmaceutical production such as EHEDG, ASME, EU-GMP, cGMP, FDA and GAMP5 guidelines.

Quality ISO 9001
Environmental management system ISO 14001
Occupational health and safety management system OHSAS 18001




Technical Data


Size

Design with vertical door

Width x Depth x Height

  • PDC800: 1470 x 1200 x 950 (850 x 800 x 950 mm )
  • PDC1200: 2200 x 1820 x 2495 mm (1250 x 1200 x 950 mm)
  • PDC1600: 2420 x 1820 x 2495 mm (1470 x 1200 x 950 mm)

Design with horizontal door

Width x Depth x Height

  • PDC800: 2150 x 1400 x 2495 mm (850 x 800 x 950 mm)
  • PDC1200: 2950 x 1800 x 2495 mm (1250 x 1200 x 950 mm)
  • PDC1600: 3350 x 1800 x 2495 mm (1470 x 1200 x 950 mm)

Values in brackets refer to the usable chamber size




More information





Contact


Prause
Stefan Prause
Mueller logo Müller Processing
Sales and Project Engineer
E-Mail
 +41 61 416 14 18