High Volatge Leak Detection (HVLD) Technology
Based on annex 1 of good manufacturing practice (GMP) hundred percent container closure integrity testing (CCIT) of parenteral pharmaceuticals should be implemented before such medicines reached to the users. There are various deterministic and non-destructive methods suggested by Package IntegrityEvaluation—Sterile Products USP 1207. Among those methods HVLD is one of the most reliabe approaches that not only can reveal the existance of a leak by also the location of it. High voltage leak detection technology works by comparing the electrical current passing through inspection and detection electrodes at two different location of the products. In case of a defective product, this current increases since current has a conductive path through the liquid inside the container. By comparing this over-current to that of good product’s current defective products can sorted out from the inspection batch.
Portable and user-friendly HMI management system
This machine offers a portable HMI system which demonstrates all the production, batch, recipe, alarm etc. data in an easy to manage and operate way. Both oxygen concentration as well as metal detection data of each vial will be demonstrated together at the same HMI system. In addition, the metal detector part comes with a separate HMI system which controls the main conveyor setting.
Features of the NT-HSGA combined machine
- Non-intrusive and non-destructive during production, storage or laboratory use
- Fast and reliable oxygen sensing
- Low headspace measurement
- Eye-safe laser light
- USP1207 recommended
- Speed up to 300pcs/min
- Vial sizes up to 30mm can be inspected
- SUS304 φ 0.2mm × 2mm detection capability
Sensitive and accurate magnetic metal detector
Magnetic metals mixed into the product are magnetized by the magnetic gate on the inlet side of the conveyor. This enhanced magnetic field is then detected by the special magnetic sensor. Although stainless steel is a non-magnetic material, it becomes magnetic metal when cutting, bending or other forces are applied to it during processing or when it is missing. Further, this metal part will be magnetized through the magnetic gate. On the other hand, since aluminum is not magnetized even if aluminum is used for packaging, it is possible to detect only magnetic metals that are mixed without any effect. Hence it is possible the inspect vials with aluminum caps.
| Model | Size | Capacity | Electric Supply | Compressed Air | Weight |
|---|---|---|---|---|---|
| HDB-II AST/ASR |
(Ampoule/Vial) | AC 200 to 480 V, 50/60 Hz, 3 phase 2KVA |
50 to 80 p/min. | 1200 to 1400 kg | |
| 10 to 13 mm dia. | 24,000 pcs/hour | ||||
| 13 to 18 mm dia. | 18,000 pcs/hour | ||||
| 18 to 26 mm dia. | 12,000 pcs/hour |
Inspection Principle
High voltage (V) is applied from inspection electrodes to a specific area of a sealed container made of non-conductive material. If the inspection area of the container is defective, current flows through pinhole, crack, or improperly sealed area in the solution (R) of the container. As a result of the loss of Z1 resistance in this figure, a change occurs in the amount of current. Detecting this change in the amount of current makes it possible to recognize the presence of a defect. The current is converted to a readable VDC in the electronic circuit to be displayed on the operation panel.
Current Calculation by Equivalent Circuit
Detection Accuracy
Our high voltage pinhole inspection machine has technology that can reliablly detect even as small as 0.1 μm holes. These tiny holes cannot be found by human eyes or visual inspection. Our pinhole machines assure container closure integrity by targeting 0.1 μm holes which are even smaller than those φ0.2 μm of the filling filter mesh.
Software & UI
21CFR Part 11 & EU GMP Annex1 compliance and USP1207 recommended
Nikka Densok user friendly data management software and human machine interface (HMI) guarantees regulation compliance Our software and HMI system makes it easy to manage the production data, inspection result data and signal trends with excellent display visibility.
Based on 21CFR part 11, various group management access levels can be defined based on user requirements to define various access levels. In addition, we offer data backup and transfer for both local folder or LDAP. Furthermore, event, alarm etc. data an be easily managable and accessible for print.
Inspection Performance Validation
A specialized processing service company can create holes by laser drilling in microns. They are reliably detected by our machines. Nikka Densok cooperates with domestic and overseas laser processing service companies to support customer validation.
Furthermore, we are equipped with a KEYENCE laser hole drill equipment which can be used to make pinholes of around 50micro meters.
The test kit is a daily challenge support tool that allows the user to check the machine readiness before production. They are created based on the shape of the customer’s container. Resistance whose value is changed for good and defective products is arranged according to the electrode configuration of the machine. By passing them through the machine, it is possible to confirm that sensors from infeed to discharge, circuit and component for judgement, sorting and signal display function properly.
