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Weighing Booth

Weighing Booth

The weighing booth with laminar air flow is designed for sampling and weighing of active materials for pharmaceutical production (API) up to OEB4 level

The weighing booth is used as a safe space for weighing and sampling active, pharmaceutical material. It consists of a work and service space. The work area is equipped with air conditioning for safe air extraction. A weighing system for manual weighing is usually installed in the interior of the box.

Description

  • The isolator is designed with a partition wall system and it’s permanently installed in a place chosen by the customer.
  • The device is equipped with a complete ventilation system dimensioned to ensure its required flow and speed in the work area.
  • Purity class “C” according to the EU GMP standard.
  • The isolator works in a vacuum mode towards the surroundings.
  • The laminar flow velocity 0.45m / s according to GMP is electronically controlled.
  • The isolator is controlled via a touch panel.
  • The isolator is supplied with room air via the PVC inlet lamellas.
  • Laminar airflow isolators when sampling and weighing active materials for pharmaceutical production are designed to perform the following functions:
    • protection of the operator during multiple handling of a material
    • prevention of contamination of sampled
    • ensuring of the cleanliness of the environment as required
  • The isolator contains a three-stage filtration. The extract air from the chambre is filtered through a pre-filter of class M5, HEPA filter in the BIBO box and continues through the plate filter H14 (installed in the ceiling) back into the chambre (the air circulates).
  • The electrical switchboard and the cooling unit are located in the technical part of the box which is accessible from the outside.
  • To illuminate the box energy-saving LED luminaires with an intensity of 500lx which come in white and red option are used. The required light intensity can be set for both options. The lighting is controlled by the control panel. The isolator is equipped with speed, temperature and pressure sensors.
  • The internal construction of the box is made of stainless steel AISI 304.
  • The outer surfaces are made of white comaxited metal RAL9016.

Operating conditions

  • The device normally works in two required operating conditions with function of the ventilation system ensured:
    • Muted mode: 0,20 m/s ± 20 %
    • Operating mode: 0,45 m/s ± 20 %
  • The operating conditions of the device are divided according to the required speed of the descending laminar flow. The laminar flow is sensed by a speed sensor which is designed for demanding applications with laminar flow.
  • The required laminar speed values can be set according to the user’s requirements. 

Operational readiness

For the operation of the device must be ensured the following:

  • connection 3L+N+PE, 400V / TN-S, AC / 50 Hz,
  • Refrigerant connection – Propylene glycol 40% 7-12°C
  • The HVAC in the room must be switched on

The device complies with

  • 21 CFR part 210/211 Current Good Manufacturing Practice
  • EU GMP Guideline Vol.4
  • USFDA Industry Guidelines: Sterile Aseptically Prepared Medicinal Products – Current Good Manufacturing Practice
  • ELOT HD 384 for electrical installation
  • ISO 14644

Parts

Weighing Booth - Parts
  1. Switchboard
  2. Control pressure sensors
  3. Sockets – 4 pieces, IP54
  4. Speed sensor  - located 100 mm from the laminator
  5. Laminator, multilevel filtration, luminaries for white and red lighting
  6. Touch control panel, main switch, stop-start switch, start button and light signalling 
  7. Suction grid and pre-filter
  8. Complete air conditioning system including bibo box
  9. Exhaust to create vacuum
Weighing isolator - Equipment
Weighing isolator - Equipment
Weighing isolator - Equipment
Weighing isolator - Equipment

Display

HMI Panel

The isolator is equipped with a control system. For operation it is equipped with a colored Siemens touch panel which is located on the left side of the working chamber. Siemens‘ Simatic control system creates an intuitive and user-friendly environment. The control panel displays the measured values of the isolator (laminar flow rate, temperature, etc.), warns of emergency conditions (eg. sensor or fan drive failure) and allows the operator to change operating modes.

Weighing isolator - Display

Overview of Functions

  • Display of physical values measured inside the isolator
  • Switching operating modes of the device
  • Control of lighting and sockets, login to the system. After logging into the „Menu“ a change of the required parameters of the laminar speed in the isolator is possible.

Drawings

Weighing Booth

Weighing Booth

External dimensions in mm

Width 2520
Height 2630
Depth 3000

Internal dimensions in mm

Width 2400
Height 2050
Depth 1775

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