MARKETS
Weighing Booth
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 RAL901
ADDITIONAL INFO
Operating conditions
Operational readiness
The device complies with
- 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
SIMILAR PRODUCTS
