Within the pharmaceutical production process there are two very important steps that take place in the first phase of the production process, namely the sampling of raw materials and the weighing or dispensing of pharmaceutical ingredients. Both processes must be carried out in a safe environment for both product and operators.
Depending on the toxicity level of the product, the best containment and operator protection strategy must be decided. With LITEK PHARMA’s family of sampling and weighing booths, we can guarantee a safe working environment up to OEL levels between 50 and 100µg/m3 and down to OEL values below 15µg/m3 with additional protection such as glove shields.
LITEK PHARMA weighing, and sampling booths can be operated with recirculated air flow and as an option can be operated with 100 % outside air. All of them have a vertical unidirectional flow that generates an ISO 5, sterile environment that allows sampling and weighing operations to be carried out with the maximum guarantee for the product.
The vertical unidirectional flow of the booth carries away any dust particles released in the sampling and weighing processes, thus protecting the operators. The air extraction is made from the lower part of the booth, thus facilitating the unidirectionality of the air flow.
In general terms, the booths are configured to work in negative pressure, since part of the air flow is driven through the front of the booth, allowing a balance of air flows that guarantees a negative pressure gradient inside the booth, which in turn prevents any particle of powder treated in the process from leaving the booth.
Within these laminar flow booths, multiple packages, and formats in which pharmaceutical ingredients are presented, such as drums, bags, pallets or other containers, can be introduced.
Booth made of AISI 304 stainless steel.
Ventilation through high efficiency EC fans.
Air velocity probe.
Filter fouling indicators and signalling.
Built-in electrical panel.
Power sockets and data sockets.
Siemens PLC and HMI
Made of AISI 316L stainless steel sheet, or lacquered steel sheet.
Integration of different components, depending on applications:
- Container handlers
- Drum lifter/turner
- Weighing scales.
- Vacuum product transfer system.
Validatable Electronic Data Recording Software, 21 CFR Part 11, GAMP5.
Viable / and non-viable particle monitoring
Temperature and humidity monitoring
Temperature control, by means of customer’s 7/120C water or autonomous cooling system.
BIBO Safe Change Filters.
PVC slat curtains
Stainless steel fixed locks, and roll-up or sliding doors.
Protective and glove-accessible screens, with several axes of movement.
ATEX environment ready.
Gas intakes: compressed air, nitrogen.
- User Manual
- Functional Design Specification (FDS)
- Functional Specification (FS)
- Hardware Design Specification (HDS)
- Software Design Specification (SDS)
- Factory Qualification Test (FQT)
- Factory Acceptance Test (FAT)
- Installation Qualification (IQ)
- Operation Qualification (OQ)
- Site Acceptance Test (SAT)
Please do not hesitate to contact us if you require any further information.