Heinkel USA COMBERPressofiltro®Steam Sterilizable Agitated Nutsche Filter / Filterdryer PF 100

PF 50 - PF 6000

COMBER Pressofiltro® Steam Sterilizable Agitated Nutsche Filters / Filterdryers

Steam sterilizable Pressofiltro® agitated Nutsche filter dryers are designed to maintain full sterility during the entire process, from inerting through slurry feeding trough filtration, washing and drying until and including the discharging of the dry product.

CIP and SIP provide a very effective, safe and convenient form of sterilization, easy to automate and validate. COMBER Pressofiltro® steam sterilizable agitated Nutsche filter dryers are increasingly being used for biotechnological and pharmaceutical filtration and drying tasks in aseptic environments.

Steam sterilizable filter dryers allow for full validated sterility during the filtration and drying process in production lines for API's, intermediates and fine chemicals.

• With Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) systems designed for the automatic cleaning and disinfecting of the equipment.
• The steam sterilizable filter dryer design assures steam reaches all parts of the filter dryer in contact with the product and air is not trapped in the unit during sterilization.
• In compliance with cGMP and FDA guidelines, with vessel interior and all associated piping designed to prevent product adherence and to facilitate cleanability, fully drainable for clearance of condensate during the heating process, with aseptic design for flanges, seals, valves etc.
• With steam traps, CIP waste discharge and temperature sensors for SIP endpoint detection located at the end of all drainage lines.
• Double mechanical seals, externally interchangeable, dry running with debris well, steam sterilizable.
• Ancillary items such as discharge valve, sampling valve, heel break up and heel removal systems all designed for steam sterilization.
• Additional temperature sensors to monitor the sterilization process located in areas difficult to reach for steam within the vessel and piping, assuring these areas are equally sterilized.
• Clean room exterior design with forced ventilation for drive unit enclosure.
• Other design criteria as per the pharmaceutical design Pressofiltro® agitated Nutsche filters or filter dryers.

PF 5 - PF 2000

Pressofiltro® Agitated Nutsche Filters / Filterdryers with Containment System

Containment devices (Glove boxes) allow for contained sampling, product discharge and packoff into lined drums or other containers, heel removal for total product recovery as well as filter cloth disposal while fully protecting the operating personnel and at the same time preventing contamination of the product. The isolator is installed on the filter dryer using an adaptor flange around a discharge plug.

Depending on the degree of containment specified, passive or active, single chamber or multiple chamber isolators are required.

Passive isolators, used for less demanding containment requirements, are operated under ambient pressure and are vented to the exterior using HEPA filters.

Active isolators operate under a slight vacuum to prevent powder or gas exiting the containment. Air is extracted from the interior using a fan and double HEPA filters, with air or nitrogen purging through an inlet HEPA filter. The isolator interior pressure is monitored, the extraction rate is raised if a pressure drop indicates containment breach e.g. by a damaged glove. The HEPA exhaust filter differential pressure is also monitored to alarm the onset of filter blockage.

From the isolator product is discharged through a bag out port, continuous liner, active valve etc. into drums or other types of containers.

Side bag in / bag out ports or side RTP's are provided to move items such as sample bottles, tools, etc. in and out of the isolator.

A wash gun permits cleaning the isolator interior, CIP spray balls may be installed additionally. Other accessories include a rake for heel removal, a glove port barrier to prevent the operator from reaching into the unit unless it is safe to do so, hinged front doors, interior lighting, etc.

All filter dryer and isolator functions are monitored and interlocked to assure the safe function and operation of the equipment.

Special properties for the customer's benefit

• Additional sensors and control system to find out when the sterilization process finishes
• Validatable steam sterilization
• Calculation, design and manufacture in compliance with Pressure Equipment Directive 97/23/EG or/and ASME pressure vessel code, section VIII, with U-stamp as well as with cGMP and FDA guidelines
• EG type examination certificate 03ATEX0246X per the 94/9/EC directive, or with electrical components UL approved for operation in a Class 1, Division 1 or 2, Groups C&D environment
• Double mechanical seal, externally interchangeable, non-contacting gas-lubricated (lift-off), dry running contact (contacting sliding surfaces) or liquid-lubricated seal
• Sampler valve
• Hydraulic pre-piping made of stainless steel, pre-wiring on terminal box made of stainless steel
• Integral CIP-/ SIP System

Options:

• Additional heating with microwaves to reduce the drying process
• Pressure-resistant and sterile versions, isolators (glove box), DQ, IQ, OQ qualification
• Autonomic PLC control or connected to PMSX, heavy current box

PF 5 - PF 500

Pressofiltro® - Agitated Nutsche Filters / Filterdryers Pilot Units

Pressofiltro® pilot units are multipurpose tools for pilot plant or laboratory applications as well as for small scale production facilities. Versatile use of the equipment, cGMP compliant design, containment, efficient and complete cleanability, complete discharge-ability, highest drying efficiency, process safety and monitoring, ease of validation and a compact design are important requirements for this type of equipment.

Pressofiltro® pilot nutsche filters and filter dryers designed to meet varied customer specifications. Customer specified options include single column support, support on a skid or conventional 3 leg design, hydraulically activated discharge valve or manually operated discharge port, active or passive isolators for sampling, product pack-off and heel removal, heel removal systems, microwave duty preparation, all electric versions, bayonet or C-clamp locking for filter bottom, etc.

Special properties for the customer’s benefit

• Calculation, design and manufacture in compliance with Pressure Equipment Directive 97/23/EG or/and ASME U-stamp as well as with cGMP and FDA guidelines.
• EG type examination certification 03ATEX0246X in accord with PED 94/9/EG or with UL-approved electrical components for operations in class 1, division 1 or 2, group C & D environment.
• Double mechanical seal, externally interchangeable, gas-lubricated (lift-off), dry running contact (contacting slide surfaces) or liquid-lubricated.
• The tank’s lower section is fastened to a column for optimal access to filter plate, resp. dryer’s lower section.
• Device built on skid, completely with hydraulic power unit or fastened to supporting column.
• Sampler valve.
• Pre-piping made of stainless steel, pre-wiring on terminal box made of stainless steel
• CIP System.

Options

• Additional heating with microwaves to reduce the drying process.
• Available in steam sterilizable and/or aseptic designs, removal of the residual layer, DQ, IQ, OQ qualification.
• Autonomic PLC control or connected to PMSX.

PF 100 - PF 6000

Pressofiltro® Pharmaceutical Design Agitated Nutsche Filters / Filterdryers

Pressofiltro® PF nutsche filters or filter dryers are versatile units designed for multipurpose production facilities. To meet the demanding requirements for filters used in the manufacture of pharmaceutical ingredients, the filters are designed to meet stringent cGMP and FDA guidelines.

To allow for good cleanability using CIP systems and to permit optimal inspection after the cleaning process all product wetted surfaces are designed without dead areas, with smooth transitions of internals and without any bolted connections. For good access to the filter internals for cleaning and inspection purposes the filters are equipped with an openable filter base. The overall attention to design details allows for simplified validation of the units.

The agitator is supported from the top, with the agitator drive, the bearings and the shaft seal installed externally. Shaft sealing is with a double mechanical seal and a convoluted bellows. The agitator arms with specially designed bottom teeth smooth and press the cake when rotated counterclockwise, and mix and agitate the cake when rotated clockwise. Simultaneous rotational and vertical agitator motions result in a very efficient and even mixing of the entire product mass for mixing and drying. The agitator arms are S-shaped for improved product discharge.

All product wetted surfaces are heated to obtain the largest possible heat exchange area for short drying times and a low attainable final humidity. Supplemental microwave heating is available to further reduce drying times.

The product is discharged through a hydraulically operated side discharge valve, with the valve plug contoured to match the curvature of the vessel internal wall. The solids discharge valve is a metal to metal seal design with the sealing surfaces arranged outside the product flow path, with interchangeable seal rings. This assures proper sealing even after multiple operations during a batched discharge.

Alternatively the product can be discharged through an active or passive isolator (glove box). On smaller filter units the isolator permits contained sampling, product discharge and heel removal all in one system. For larger filters different heel break-up and heel removal devices are available.

Standard Features for Pharmaceutical Version:

• Calculation, design and manufacture in accordance with PED 97/ 23/ EC or /and ASME pressure vessel code, Section VIII with U-Stamp as well as in compliance with cGMP and FDA guidelines.
• EC type examination certificate 03ATEX0246X per the 94/ 9/ EC directive or with electrical components UL approved for operation in a Class 1, Division 1 or 2, Groups C & D environment.
• Double mechanical seals, externally interchangeable, dry running contacting or non-contacting lift-off type seals as well as liquid lubricated seals.
• Sample valve
• Hydraulic pre-piping to manifolds, pre-wiring to terminal boxes, all in Stainless Steel.
• CIP System.

Options:

• Supplemental microwave heating to reduce time required for drying.
• Aseptic versions, heel removal systems, contained discharge (Glove Box), DQ, IQ, OQ qualification.
• PLC controls, autonomous or slaved to DCS, MCC.