Product Description
MK-500 Non-Destructive Leak Tester,Adopting a non-destructive test method and using the vacuum decay method test principle, it is specialized in micro-leakage and package seal integrity testing of ampoules, vials, injection vials, lyophilized powder injection vials and pre-filled packaging samples.
Features
★ For different test samples can be equipped with corresponding test chamber, the user can easily replace, in order to meet more kinds of samples, minimize the cost of the user, so that the instrument has a better detection of adaptability.
★ Suitable for detecting small leakage holes, but also can identify large leakage hole samples, and give qualified and unqualified judgment
★ Adopt non-destructive testing method to detect the leakage of the package containing the drug, no damage to the sample after the test does not affect the normal use of the test, low test cost.
★Non-subjective judgment of the test results, each sample testing process is completed in about 30s, without manual participation, to ensure the accuracy and objectivity of the data
★ Branded vacuum components for stable performance and durability
★ Instrument can perform qualitative and quantitative testing
★With adequate password protection, divided into three levels of authority management, each operator has a unique combination of login name and password to enter the instrument operation
★ Meet the GMP requirements of data local storage, automatic processing, statistical test data functions, and export in a format that can not be modified and deleted, to ensure that the test results of the permanent storage
★The instrument comes with a micro-printer, which can print the serial number of the equipment, sample lot number, laboratory personnel, test results, test time and other complete test information.
★ 10-inch embedded industrial control all-in-one machine, humanized operation is more convenient
★ The instrument is equipped with RS232 serial port to support data transmission over LAN and ISP online upgrade function to meet customers' individual requirements.
★ User hierarchical authority settings to meet GMP requirements, test records audit trail function
Principle
Fully compliant with ASTM F2338-09 standard and USP 40-1207 regulatory requirements, based on the principle of vacuum attenuation method with dual sensor technology and dual circulation system. The main unit of the Micro Leakage Tester is connected to a test chamber specially designed to hold the package to be tested. The instrument evacuates the test chamber, forming a pressure difference between the inside and outside of the package. Under pressure, the gas inside the package diffuses through the leakage holes into the test chamber, and the dual-sensor technology detects the relationship between time and pressure changes, compares them with the standard values, and determines whether the sample is leaking or not.
Standards
This test instrument conforms to many national and international standards:
ASTM F2338 ,USP1207 ,YY/T 0681.18-2020
Applications
| Basic Applications |
For microleakage detection of ampoules, vials, injection vials, lyophilized powder vials and pre-filled packaging samples. |
Product Parameters
| Items |
Specifications |
| vacuum |
0 ~ -100 kPa |
| detection sensitivity |
1 ~ 3 μm |
| Testing time |
Around 30 s |
| Equipment Operation |
Self-contained HMI |
| test system |
Dual Sensor Technology |
| Vacuum Source |
External vacuum pump |
| test chamber |
Customized according to samples |
| Applicable products |
vials, ampoules, pre-filled seals (and other suitable samples) |
| Detection Principle |
Vacuum attenuation method/non-destructive testing |
| Instrument Dimension |
520 mm(L) × 320 mm(B) × 350 mm(H) |
| weights |
20 kg |
| environmental temperature |
20ºC ~ 30ºC |
| relative humidity |
Up to 80%, no condensation |
| Power Supply |
220 V |
Configurations
Standard: Main unit, vacuum pump, micro printer, embedded computer, test chamber
Optional: Micro flow meters, positive specimens, test chambers of different sizes
Company Profile
Jinan Saicheng is a professional manufacturer founded in 2007 which focuses on producing and developing R&D of laboratory testing instruments and packaging testing devices.
Since the establishment of the company, it has provided various testing instruments and systematic solutions completely for packaging, pharmaceutical, food industry, quality inspection institution, scientific research institution, daily chemical industry. It has achieved ISO 9001 certification and is recognized as a high-tech enterprise by the national authority.
Our Advantages
Jinan Saicheng Instrument adheres to independent research and development, continuous innovation, and focuses on R&D investment. The company is equipped with a high-quality, high-level R&D team. It holds complete independent intellectual property rights and is currently leading or participating in the drafting of national standards. The company has over 50 patents, including invention patents, utility model patents, and software copyrights. It has passed the evaluation for high-tech enterprises, provincial specialties, and new enterprises. Additionally, the company has obtained software enterprise and software product certifications, as well as ISO 9001 quality management system certification.
1. Strict Quality Control System
Ensuring the highest standards in every product ,our factory has a strict quality control system. Each shipment of our orders undergoes five inspection steps: materials checking, production process monitoring, finished product testing, equipment packing, and loading. When any problems arise, it's easier to resolve the issues quickly.
2. Perfect Packing and Shipping
Ensuring safe and secure delivery of our products ,the shipping department will prepare a checklist and pack the items in a wooden box. You will receive a checklist with everything we shipped. After shipping, we will provide completed loading pictures and a checklist with images of all parts.
3. High-Efficiency After-Sales Service
Ensuring prompt & effective support for our customers,we have a standardized and comprehensive after-sales service process. Our primary goal is to ensure quality in advance to minimize after-sales issues. If any problems arise, we address them with the highest efficiency, whether by sending replacements or covering repair costs.
Certifications
Exhibition
Packaging & Shipping
FAQ
1. Is your company a trading company or manufacturer?
We are a factory. All testing instruments are R&D and Manufactured by Saicheng with almost 20 years of experience.
2.Do you accept customized services?
Yes, of course, we can not only provide standard instruments but also customized instruments according to your requirements. Please tell us your requirements, we will try our best to meet your needs.
3.How long is your delivery time?
Generally, it is 5 working days after we receive the payment or order confirmation.
4.How about your warranty?
Usually, our warranty period is 12 months. During the warranty period, we can provide technical support and parts replacement. We can provide you with lifelong technical support.
5.How about the packaging of the instrument and is it protected during transportation?
Our instruments are packed in standard export wooden boxes and will not be damaged. We have delivered many test machines abroad by sea or air without damage.
NOTE:As prices vary for different products, please confirm your order after discussing with us.
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