Filter Integrity Test System
A filter Integrity Test System is available. In-situ integrity testing of aseptic system filters can be performed on the air and product filters installed on the machine. The test circuits are set up automatically for each product filter through an auxiliary panel provided on the machine. All integrity test attachments are directly incorporated into the filtration circuit. This highly sensitive instrument is designed for use in all locations including the laboratory or inside the process suite or cleanroom. This test instrument is fully compliant with 21CFR part 11 for electronic and data record storage.
KleenKut® Parison Cutoff Mechanism for LDPE Resin
Designed to dramatically reduce non-viable particulate generation in the parison extrusion zone, the KleenKut® is a new method for cutting the molten parisons during the blow/fill/seal process. The cut-off is accomplished at ambient temperature with a set of ultrasonic knives, eliminating the non-viable particles (smoke) typically generated from a hot knife.
The KleenKut® offers an additional benefit of an improved measure of safety over conventional cut-off techniques. Available only for low density polyethylene resin applications (LDPE).
Secure collection, logging and reporting of critical operating data can be enabled. A software program is provided to permit assignment of a password to each employee. When the employee logs in an ID record is made with date and time. Changes showing both the previous and new value entries are recorded on a storage media located on the HMI.
Parison Shrouding System
A two component package is available to enhance the environmental process conditions within the extrusion zone of the ASEP-TECH® machine . HEPA filtered air is supplied to an enclosed area encompassing the parison head and mold transport area of the ASEP-TECH® machine. Air flow to this area is monitored with a flow sensor and alarmed to ensure consistent operation. Control of this “zone of protection” reduces effects due to potential changes in the machine room environment.
A secondary stainless steel collection shroud encloses the parison head and is coupled to an exhaust system with an external blower to be mounted outside the clean room within 30’ (9 meters) of the ASEP-TECH® machine.
This combination system helps ensure that typical non-viable particle counts in this area will meet US FDA Class 10,000 under dynamic conditions.
An airborne particle counter can be provided for continuous environmental monitoring of the nozzle shroud. Count programming, capturing and recording is available through an electronic interface. The data can be sent directly to the temperature/process controller or linked to a customer-supplied system.
A maintenance cart on casters with a height-adjustable lifting plaform and safety brake is available for transport/installation of custom tooling. Fixtures specifically designed to assist with the removal and installation of the mold(s), fill nozzle assembly and parison head are included, when this cart option is selected.
Fully automatic or manual-load slitter/singulators can be provided, custom designed to enable separation of containers after the deflashing station. The designs permit complete separation of each “pack” to produce different combinations (singles, 2-packs, 3-packs, etc.). Alternatively, blade spacing can be set to produce an initial (or partial) separation at the parting lines of the connected containers while keeping the original “pack” partially attached to enable downstream material handling (labeling and leak detection).
This is very important when Polypropylene is the resin of choice, since the characteristics of this resin can make separation of individual containers difficult. The slitter helps minimize this difficulty by initiating the separation without human intervention.
Blades are double edged to permit easy, rapid changeover to minimize down-time. Included is a spare blade module, mounted in a convenient storage location.
Viable Particulate Microbial Sampling Tube
The viable particulate monitoring tube is a device which is affixed to the Blow/Fill/Seal machine above the Class 100 nozzle shroud. The viable particulate monitoring tube is partially inserted into the Class 100 environment so an adequate and representative sample of air can be withdrawn from the Class 100 environment. The sweeping elbow design of the viable monitoring tube ensures a smooth transition between the Class 100 environment and the customer supplied sampling device. The tube is fabricated from 316L stainless steel with a 1 inch Tri-Clover connection on the downstream side, to be adapted to the customers sampling device.