- Automatic and semi-automatic machines for the control of the flasks for perfusions
- Automatic machines for the cosmetic control, the level of filling and the visual inspection of the ampoules and Brevetti-flasks
- Machines for control of empty/full ampoules
Machines for the control of full ampoules used at:
- stating of defects;
- the verification of the tightness;
- the verification of the level of filling;
- signalizing of the presence of particles;
- the cosmetic control;
These machines can also be used in the case of the verification of the bottles which contain parenteral liquids. The control is completely automated according to GAMP, and the results are electronically registered together with the electronic signature according to FDA 21 CFR part 11.
Systems of takeoff and control of the bacteriologic contamination within the sterile spaces achieve the numbering of the particles existent in the air, for the microbiologic control in the clean rooms. The system, fixed or portable, is capable of simultaneously controlling 8+8 lines of takeoff of the samples, the results being reproducible, continuously monitored or typed. Each takeoff line ensures a flow of 25L/min for assuring the dynamic conditions necessary in guaranteeing the limitation of the stress of the taken off microorganisms.
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- Machines for control of blisters
Automatic, semi-automatic machines for the control of blisters - numerous advantages:
- "Leak test" is a rapid (max. 5 sec.) and nondestructive test;
- Capacity of control: up to 900 pcs./h
- It can be achieved both at pressure and under vacuum;
- It offers a very high accuracy of the determinations for cracks of up to 5 μm opening, the limit of detection existent under the human limit of visual detection;
- There may be identified with accuracy the position of the defect in the blister. On the basis of this determination there may be performed the afferent adjustments for the blistering equipment, in order to eliminate the defects appeared during the formatation.
- The testing method is a standardized method according to ASTM F2338-05 ("Standard test method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method"), acknowledged by FDA (U.S. Food and Drug Administration)
Combined - Leak Testing + Visual Inspection
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- Machines for control of phials
- Automatic and semi-automatic machines for the control of phials with lyophilized products - are used for the control of the tightness of the flasks by measuring the level of vacuum inside them, either with the help of spectroscopy with laser absorption, or by performing the leak-test under pressure or vacuum. The test is performed rapidly (max. 3 min.), precisely and nondestructively. The maximum capacity of control: up to 600 flasks/min.
- Automatic and semi-automatic machines for the control of the phials for perfusions - they detect in a rapid way (max. 3 sec.) and nondestructively any orifice in the material, with a diameter of 5 μm, the test being performed either under pressure, or under vacuum. The capacity of control: 6000 flasks/h.
- Automatic machines for the cosmetic control, the filling level and the visual inspection of the ampoules and Brevetti-flasks.
- Machines for visual inspection
- automatic machines for the macroscopic control of ampoules or of flasks with solutions or they can simultaneously and rapidly achieve both their cosmetic control and the level of filling and the presence of certain particles. The equipment is flexible and it can be connected both in upstream and in downstream. (pictures in doc. 1, 3, 4). The capacity of control varies between 9,000 and 24,000 pieces/h.
- automatic machines for the control of the syringes pre-filled with clear solutions or suspensions offer a high productivity due to the fact that they simultaneously perform the cosmetic control for particles, as well. (pictures in doc. 5, 6, 7, 8). The capacity of control varies between 8,000 and 36,000 pieces/h.
- automatic machines for flasks filled with solutions for perfusions or with
lyophilized products simultaneously control the level of filling, the cosmetic control and the content of particles. The capacity of control of up to max. 12,000 pieces/h for flasks with a volume included between 10 ml and max. 1,000 ml (see doc. 9).
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