QUALITY AND ECONOMIC EFFICIENCY OF INSPECTION-METHODS
M. Kardel¹, G. Kutz¹, R. Rosito², H. von Zydowitz²
¹Pharmaceutical Engineering, FH Lippe und Höxter, University of Applied Sciences, Detmold, Germany ²Esx Animal Health, Friesoythe, Germany四六级成绩查询时间2020
efficiency of an inspection system [1]. It is bad on a comparison between the efficiency of an inspection system already existing and a new one.
The Knapp-Test is performed using a test t with 80 injection vials containing particles and 170 non inspected vials of the same product. The statistical rejection probability of each vial is determined first by the manual inspection (4x magnifying lens), whereas 5 inspectors have to inspect each test vial 10 times, and then by the new automatic inspection machine, whereas the machine has to inspect each vial 10 times. The efficiency is calculated with defined formulas. If the ratio is equal or greater to 100% then the new inspection system is equivalent or better than the existing one [2,3].
• Test-t with prepared vials
雅思试题This test includes the control of particles as well as other defects like deviations on fill level or colour, gl
ass or cap defects. After examining the test with the four systems the results are evaluated to determine their recovery rate of defective containers and their fal rejects.
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做鬼脸 英文2. Economic efficiency • Speed of the systems
The productivity depends on the different speed of the visual inspection. The efficiency of the systems and the inspection time per vial
depending on the size of the vial are taken into consideration.
• Capacity of the systems
The capacity shows how many vials of the annual production of Esx Animal Health can be inspected by the different systems. The time and the staff needed for inspecting 3,4 mio vials with an inspection method is calculated.
• Comparison of the costs
First the fixed and variable costs are t up. Then a break-even calculation was made with the systems. The annual costs depending on the produced vials are also taken into consideration.
Introduction
The manufacture of sterile products is subject to special requirements to ensure continuously high quality.
One of the requirements is the visual
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inspection of each filled container for particulate contamination.
Two methods are ud for this process:
1. Manual inspection, which depends
subjectively on the inspector
2. Automated inspection with camera
systems.
A validation of a manual inspection is not feasible due to the lack of reproducibility. Generally, the inspection process should be
automatized. On the other hand high costs for the machine and validation studies should be taken into consideration. From August 2004 to January 2005 studies were performed at Esx Animal Health Friesoythe, a Division of Esx Pharma Germany, to evaluate the efficiency of manual and automatic inspections methods. Four
different inspection methods were available and compared:
1. Black and White Box according to
Ph.Eur. 4
2. Control Unit for Particles and Bottles
with the aid of a magnifying glass (manual inspection)
3. Semi-automatic inspection machine
(manual inspection, but automatic product transportation)
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4. Fully automated inspection bad on
camera system evaluation.
The systems were analyzed systematically in respect to their quality and economic efficiency. The purpo of the study was to find out if a fully automatic inspection machine really shows a higher quality and better economic efficiency than manual systems.
Investigations on quality and economic efficiency
1. Quality • Knapp-Test
The Knapp-Test is ud to determine the
Results and Discussion
1. Quality Knapp-Test
The calculated efficiency of the automatic
inspection versus the manual inspection amounts to 103,83%. Conquently the new fully
automated method is considered superior to the existing one. In addition the test supports the higher
reproducibility of the fully automated machine.
Test-t with prepared vials
The fully automated inspection machine as well as the manual Control Unit shows recovery rates of nearly 100%. On average the automatic inspection machine has the highest recovery rate of defective vials of about 97,49% with a standard deviation of about only 1,83%.
The amount of fal rejects should be as small as possible. Here the Black and White Box gave the best result followed by the automated inspection machine.
2. Economic efficiency • Speed of the systems
The following figure shows the speed of the systems.
500
1000
1500 2000 2500 3000 3500
4000 4500
5000 2
10
20
50
100
250
500
vial size (ml)
vials per
日语常用口语hour Automatic Semi-automatic Manual
Figure 1: Efficiency of the inspection systems depending on the size of the vial
The efficiency of the automatic inspection machine is more than double that of the mi-automatic inspection machine and about fifteen times more than the manual system.
• Capacity of the systems
The inspection of a production of 3,4 mio. vials shows the following results:
System Time Staff Manual 13.535 h/a 13Semi- automaticpiechart
1.799 h/a 7Automatic 685 h/a 3
Table 1: Time and staff needed for inspecting 3,4 mio. vials (working a single shift)
Comparison of the costs
The comparison refers to a production of 3,4 mio. vials.
The break-even calculation of the automated and mi-automated inspection machine shows that, after four years, the automated system (in-line) is the one with minimum costs. After already 1,5
years the automatic inspection is more cost efficient than the manual inspection. Right from the start, the costs of the mi-automatic machine are below tho of the manual control.
The calculations in the following diagram refer to one year only. For this reason the depreciation of the systems has to be considered.
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400000600000800000100000012000001400000
1600000180000020000000
3
6
9
12
15
18
21
24
Number of vials (Mio)
C o s t s (€)
Automatic Manual Semi-automatic
Figure 2: Cost trend depending on the produced vials
Only a low annual production of about 100.000
vials can keep the costs of the manual inspection under tho of the mi and full automatic inspection. When inspecting up to 1 mio. vials the mi-automated inspection machine shows a cost advantage compared to the automatic
inspection machine. From that point of view the full automatic system is the minimum-cost alternativ
e.
Conclusion
None of the four systems can guarantee a 100% detection of defective vials. According to the results of the tests the fully automated inspection machine reprents the best qualitative method. Considering the economic efficiency, especially over a long period of time, the automatic inspection machine is the minimum cost
alternative. A higher annual production would show this advantage even more. The initial high costs of the automatic system can be
compensated by its higher efficiency and by the staff savings.
In conclusion, with the focus of applications for Esx Animal Health Friesoythe the fully automated inspection machine reprents the most effective method.
References
[1] Brevetti C.E.A., Inspection Systems, The Knapp Test
- Description, Execution and Examples (2002)
[2]
Knapp, J.Z., Origin, result and measuremant of USP “esntially free” inspection for visible contaminating particles, PDA Journal of Pharmaceutical Science & technology, 54 (3), 218-32 (2000)蒙文翻译公司
[3]
Knapp, J.Z., Overview of the Forthcoming PDA Task Force Report on the Inspection for Visible Particles in Parenteral Products: Practical Answers for Prent Problems, PDA Journal of Pharmaceutical Science & technology, 75(2), 131-147 (2003)
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