Description
KEY FEATURES
- unique primary containment BioHEPA filtration system for maximum personnel, product & environment protection
- negative pressure double-wall housings for containment
- all stainless steel work zone construction with radiused corners
- ISO Class 5 (Class 100) air cleanliness work zone for absolute product protection
- Class 1000, Class 10 000 & Class 100 000 air cleanliness available
- cost-effective & versatile alternatives to the construction of dedicated rooms
- flexibility to handle large containers and process equipment
- may be placed singly or in multiples to create downflow containment rows
- may be easily and quickly assembled on site without the need for modifications to building construction
- ZERO-LEAK airflow system for enhanced safety
APPLICATIONS
Gelman PharmaCare Downflow Containment Powder Handling Booths with its Bag-In / Bag-Out (BIBO) primary containment BioHEPA filtration system meet the needs of pharmaceutical and biotechnology industries in applications involving the handling of powder, drugs and chemicals that require both containment and aseptic manipulation.
The Gelman PharmaCare Downflow Containment Powder Handling Booths provide the highest levels of operator protection from potentially harmful airborne contaminants generated during manual powder handling operations such as manufacturing,
tabletting, filling, grinding, sampling, charging, dispensing etc.
These processes generate airborne particles at varying concentration levels and may involve estrogenic or estrogenic materials,antibiotics, toxic or other harmful powders and it is essential that the operators are protected from excessive exposure and cross-contamination between products is minimized.
The Gelman PharmaCare Downflow Containment Powder Handling Booths with an air cleanliness level of better than Class 100satisfy the stringent demands of the above applications, providing total protection for : · all personnel and environment from any aerosol, particles or vapours which may be liberated in the preparation, manipulation and dispensing of drug products. · drug products so that they are prepared or dispensed in an environment free from particulates including biological matters.· maintenance and testing personnel from exposure to the residue of drug products which may contaminate filters,
mechanical components and other surfaces.
The Gelman PharmaCare Downflow Containment Powder Handling Booths are partially-recirculating laminar flow enclosures,modular in design and construction which can be installed, commissioned and tested in a new or existing process area. The booths are a cost-effective alternative to specially-designed “containment” rooms.
DESCRIPTION
The Gelman PHU Series Laminar Flow Powder Handling Systems have been designed to satisfy the stringent demands of the above applications, providing three aspects of protection, viz :
- The product is protected from ambient contamination which, depending on products handled in the process area, can be toxic/ viable or non-toxic/ non-viable particulate matter.
- The operator(s) is protected from inhalation of hazardous pharmaceutical products such as antibiotics and hormones.
- The areas external to the containment enclosure are protected from cross contamination. Airborne particulates generated in the process operation are contained within the enclosure.
PHU Series systems are partially-recirculating laminar flow enclosures, modular in design and construction which can be installed, commissioned and tested in a new or existing process area. The systems are a cost-effective alternative to specially-designed “containment” rooms.
OPERATION
The Gelman PharmaCare Downflow Containment Powder Handling Booths maintain a continuous inward airflow of ambient air into a full-width lower section of the work zone.
An effective air barrier between the operator and the work zone, maintained by the inward flow of air provides personnel and environment protection.
The barrier air blends with the contaminated work zone air below the work surface and passes through a 3-stage prefiltration system comprising of multi-pleated panel filters, high dust loading extended surface Bag filters and Bag-In / Bag-Out (BIBO) primary containment BioHEPA filters.
The prefiltered air is partially recirculated back to the work area through the supply HEPA filters on top of the work zone to create an ultra-clean work environment for the preparation of drug products.
The remaining prefiltered air is discharged to the laboratory or outside atmosphere via an exhaust HEPA filter.
GELMAN ZERO-LEAK airflow system ensures that all positive pressure zones are surrounded by negative pressure zones to contain potentially-hazardous aerosols.
