The UZS 043AT-50 ultrasonic device makes the process of cleaning the pharmaceutical tools used in tableting devices automated. Cleaning is defined by pre-defined and confirmed recipes. At the end of the cleanup, a report is generated and stored on the memory card or database.

The device is designed and manufactured according to the applicable GMP requirements, other guidelines and standards. The baths, measuring 600x380x400 mm (V = approx. 80 l), have rounded inner edges and the bottom slopes toward the drain. Just like the worktop, the baths are made of stainless steel, with 1.4404 (AISI 316L) quality and with a thickness of 2 mm. The surfaces in contact with the product have a roughness factor of Ra <0.8 µm. All pipe installations are made of stainless steel pipes, with 1.4401 quality. Other surfaces not in direct contact with the liquid are made of 1.4301 stainless steel (AISI 304) with Ra <1 µm. Other materials used are FDA compliant. A complete device construction plus locking plates are designed to allow easy access to all components. In addition to the device itself, complete documentation is provided to perform its validation (HDS, FDS, SDS, IQ, OQ, FAT, SAT, ...).

The device is controlled and operated using a secure "Fail-safe" controller and user interface (HMI / SCADA). The system enables, among other things:

  • Recording every change in the system, user’s input and output, alarm verification, etc., in the "Audit-trail" traceability table (CFR Part 11)
  • All system data is read / written to SQL server
  • Access to the system and its functions is restricted by different user groups (user, technologist, QA, administrator, ...)

The entire washing process is fully automated. This means that the baskets are transferred between individual baths by means of automatic transport, furthermore, the filling (with hot and / or cold water) and emptying of the tubs are automatically carried out. Depending on the recipe parameters, the device itself doses the right amount and type of cleaning agent.

The number of baths and their individual functions can be adjusted according to the wishes of the customer. In general, the individual sub-assemblies of the device are as follows:

  • Loading location
    • The place, where the baskets are manually inserted into the device
    • Designed as a drawer, with basket presence and drawer position detection
  • Bath 1 and Bath 2 - ultrasonic wash / prewash in warm solution
    • Ultrasonic transducers of 1 kW (30 kHz) are installed at the bottom
    • The liquid is heated by means of 3 kW heaters
    • Liquid temperature and washing time are determined by the recipe
  • Bath 3 - ultrasound rinsing
    • Ultrasonic transducers of 1 kW (30 kHz) are installed at the bottom of the bath
    • Overflow through an overflow channel – removing particulates and cleaners
    • Implemented 3 kW heaters
    • The purity is checked using a conductivity meter
    • Parameters such as rinsing time, rinsing temperature, as well as maximum allowable conductivity are defined in the recipe
  • Bath 4 - blowing water droplets and air-drying
    • Double nozzles are implemented for compressed air exhausting under the cover
    • Built-in fans for forced circulation of heated air
    • The circulating air is heated by 4 kW heaters
    • After the drying is completed, the baths and objects are cooled
    • The auto-guided lid is synchronized with the transportation system itself and is closed during drying
    • The recipe dictates the time of blow-off processes, drying time and temperature, as well as the cooling temperature
  • Output area
    • Represents the location where the transportation system disposes of the basket after washing
    • Designed as a drawer, with basket presence and drawer position detection
  • Transportation system
    • It is the task of transporting baskets / racks, from the loading point, through individual baths to the site of deposition
    • Both vertical and horizontal movements are enabled
    • The maximum load is 500 N
    • The current position is defined using position sensors (encoders)
  • Stand / baskets
    • They allow tools to be transferred throughout the cleaning process
    • Tools are placed upright throughout the process with minimal contact with the stand
    • They are entirely made of AISI 316L stainless steel and are electrically polished
    • Types of baskets / stands
      • Transport basket - allows transportation of two stands with punches or dies (matrices)
      • Stand for 49 punches of Type B
      • Stand for 49 dies of Type B
      • Stand for 30 punches of Type D
      • Stand for 30 dies of Type D
      • Stand for 3 segments of Type 2090i
      • Stand for 3 segments of Type FE55
      • Universal stand

Brief description of the cleaning procedure

An appropriate and approved washing recipe is selected at the beginning of the process. Optionally, all parameters are passed to the controller and, depending on their values, the preparation of the bath follows. In the next step, the operator places a transport basket with stands in the loading drawer. With each new series, all the liquids, along with the cleaning agents inside the bath, are replaced. The type and amount of detergent inside baths 1 and 2 are determined by the recipe. The recipe also determines the order in which the cleaning is performed. The cleaning process can start in bath 2, continue in bath 1 and 3, and end in bath 4, or in the order of baths: 1, 3, 4, etc. More baskets can be stored in the unit at the same time. Running the program on the controller ensures that transport does not dispose of the basket in the already filled bath. When the series of the cleaning process is completed, a wash report is created.

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