Dedicated to sampling and weighing of APIs and excipients in solid form prior to processing
This area is dedicated to sampling and weighing of APIs and excipients in solid form prior to processing. High containment technological equipment and strong experience in high potent APIs handling allow us to dispense products until OEB5 range.
Centrally located in the facility, the central weighing area is designed to directly receive the incoming raw materials from the warehouse for sampling, weighing and dispensing activities. Sampled and weighed products are then transported into the appropriate production areas with Intermediary Bulk Containers, Stainless Steel drums or Disposable Bags.
Sampling and weighing activities are done into a C-classified area while a common clean corridor, which is a D-classified area, will permit to enter to each main room.
Sampling activities in this area are done for all production activities (polymer forms, injectables and tablets). The room dedicated to sampling operation will be equipped with a downflow booth with a containment screen with gloves. Hazardous and non-hazardous raw materials can be sampled with this equipment.
Weighing activities are done for polymer forms and injectable products. Weighing activities for tablets are directly performed in the tablet production area. Weighing activities are segregated between hazardous substance and non-hazardous substance weighing.
The critical weighing room will be equipped with a containment isolator to protect the operator and to avoid cross contamination. The negative pressure Isolator is designed to use hazardous substances class OEB 5 (with an OEL lower than 1 μg/m³ – 8h TWA).
The room dedicated to non-hazardous weighing will be equipped with a downflow booth to prevent any cross contamination.
Risk assessment can be provided by Mithra for any hazardous substance to be handled into our facility.
Batch until 300 L can be prepared into IBC.
Batch until 50 L can be prepared into disposable bag.
Maximum 2 shifts / day
Strong experience with high potent product
Work with OEB5 product
Production in batch and/or campaign
Sampling and weighing grade C classification under isolation and flow booth
Negative pressure isolator
The isolator will be equipped with a bench scale with the following characteristics:
range: 0 – 15 kg
precision: 0.1 gr
Weighing Down flow Booth
The working area will be equipped with a bench and floor scale with the following characteristics: