Residual Oxygen Analysis in Transfusion Bags

Unplasticized PVC softener transfusion is used in a wide array of products peer. Because of its low cost and convenience in transportation and storages. Residual oxygen in the transfusion bags affects the quality and shelf life of medicines directly. Labthink HGA-01 Headspace Gas Analyzer and the parts can easily and efficiently solves the oxygen analysis in transfusion bags.

<I> Why should we control the residual Oxygen in Transfusion Bags?

Oxygen is an important factor that affects shelf life of medicine in transfusion bags. It is reported that it can extend shelf life and improve maintenance quality of medicine by controlling residual oxygen in the packages. In order to reduce residual oxygen, MAP and CAP are more and more used in the transfusion industry. Usually, Nitrogen or mixed nitrogen and carbon dioxide is used as protected gases. However, we can’t avoid oxygen in the packages. If we can’t analyze the gases proportion in the sealed packages accurately, it is hard to estimate and label the shelf life on the packaging.

<II>  HGA-01 Labthink Headspace Gas Analyzer

HGA-01 Headspace Gas Analyzer

Labthink HGA-01 Headspace gas analyzer has its unique design to make it avaible on small package test. HGA-01 adopt the advantages of benth and portable instrument and can used in online, storage, lab and whereever clients want to test. The instrument can test O2 and CO2 proportion simultaneously with high international accuracy. Equiped with professional needle, Seal Gasket and filter, along with the improvement of timing, the instrument can accuratly and efficiently test the Proportion of O2 and CO2 in the packages.

Moreover, the instrument is equipped with the best gas sensors of the world, which can ensure at least 6 years life time. To make it more convenient, the equipment has a micro printer to let you get the result no matter where you are.

Discussion

With headspace gases analysis of transfusion bags, we can get to know the inner gases of packages easily, efficiently and accurately. In further, we can estimate a proper shelf life of medicine to make it service people better.

For more information about labthink headspace gas analyzer, please contact Yarina gao via trade5@labthink or connect her on a phone 86-531-85060139. 

Oxygen Permeability Test for Contact Lenses

It’s well-known that the oxygen transmission performance of contact lenses would directly influence the feelings and experiences of the consumers, and the sales volume would be affected correspondingly. Therefore, the test for oxygen permeation performance of contact lens has become a main concern of the manufacturers. 

Owing to the importance of oxygen transmission performance of contact lenses, ISO, International Standard Organization, has formulated two relevant testing standards as follows:  ISO 9913-1, Optics and optical instruments—Contact lenses—Part 1: Determination of oxygen permeability and transmissibility with the FATT method; and ISO 9913-2, Optics and optical instruments—Contact lenses—Part 2: Determination of oxygen permeability and transmissibility by the coulometric method. The testing principle and instrument of ISO 9913-2 are similar to those of coulometric method applied in oxygen transmission rate tests for flexible packaging materials. The testing principle is as shown in Fig. 1. 

Oxygen Transmission Rate Testing principle

Testing principle

Place the sample to be tested into the testing chamber, and the chamber would be separated into two sections: upper chamber and lower chamber. Then, testing gas with a certain oxygen concentration is purged into the upper chamber. Carrier gas flow, that is, nitrogen gas flow, purges into the coulometric sensor through the lower chamber. Though the pressures of the upper chamber and the lower chamber are the same, the pressures of oxygen differ in them. Thus, oxygen would, with the help of concentration difference, permeate through the sample and into the carrier gas side. Then, oxygen would be taken to the coulometric sensor. The sensor would precisely measure the oxygen quantity in the carrier gas flow (that is, nitrogen gas flow), and calculate the oxygen transmission rate (OTR).

It can be concluded, from the above-mentioned principle, that oxygen transmission performance tests for contact lenses and flexible packaging materials have the following steps in common: first, system zero is achieved by purging. Second, oxygen gas flow is purged into the upper chamber. Third, the sensor output is stable (to determine whether transmission equilibrium has been realized). Fourth, testing results can be obtained. 

Before testing, instruments should be calibrated with reference films, so as to confirm the correction factors. Those factors would be used in formal tests. It’s stated clearly in ISO 9913-2 that the sample for calibration is SRM 1470, which coincides with the reference film stipulated in ASTM D 3985, a standard for film testing. 

However, there are differences in the tests for contact lenses and flexible packaging materials. First, the clamping structures are different. The shapes and sizes of the sample are quite different. Second, testing environments are different. The standard temperature for film oxygen transmission testing is 23℃, and that for contact lens is 35℃, so as to imitate actual temperature in usage. Meanwhile, temperature change would influence the oxygen transmission testing results remarkably, and the stability of testing temperature has become very important. 

OX2/230 oxygen transmission rate tester

Labthink, based on her professional oxygen transmission tester for flexible packaging materials, OX2/230 Oxygen Transmission Rate Tester, has specially designed and manufactured the clamping accessories and temperature control device for oxygen transmission tests of contact lenses. 

Labthink also has some other equipments that can be used to test the Oxygen Transmission Rate or Gas permeability Tester

VAC-V2 Gas Permeability Tester

Please go to our website (www.labthinkinternational.com.cn)for more details about our products.

Sealing Integrity Testing and Cap Torque Strength Testing of Stand-up Package with Spout

In recent years, stand-up package with spout, owing to its multiple open-close cap, low material consumption, high printing standard, low costs in logistics and low disposal quantity, has become a popular kind of packaging. The sealing performance and torque strength of stand-up package with spout would directly influence the product shelf-life and its properness for usage. Hereafter, we would introduce sealing performance testing of the package and open easiness testing of its cap with the help of Labthink leak tester and torque tester.
 

1. The Sealing Integrity Testing of Stand-up Packaging with Spout

MFY-01 Leak Tester

The sealing integrity of stand-up packaging with spout refers to the reliability of the packaging’s sealing performance. This test can help evaluate sealing integration of the whole package, so as to avoid leakage, contamination or deterioration caused by inferior sealing performance. There are several testing methods for sealing performance, for which, leak tester is the most common means. Labthink MFY-01 Leak Tester applies vacuum method to maintain 0.5 minute intervals at -30kpa, -50kpa, -70kpa and -90kpa respectively. As to vacuum package, revival is observed after testing. The above-mentioned method is by visual observation, and is a qualitative testing method. As to the leak and seal strength performance testing for stand-up package with spout, instrument of positive method can be used, such as Labthink LSSD-01 Leak and Seal Strength Tester.
 

2. Torque Strength Testing for the Cap of Stand-up Packaging with Spout

The cap torque strength for open and close stand-up package with spout is an important index for manufacturers for online and offline observation. Properness of the cap torque strength would greatly influence transportation and consumption. Labthink NJY-20 Torque Tester is monitored by mini-computer to realize dual testing modes for lock force and open easiness. The instrument is easy to operate with human-friendly interface. It can keep peak value automatically, display in multiple units, and carry out statistical analysis. Labthink NJY-20 Torque Tester is precise in measurement and stable in performance. It’s a necessity for production.

When sealing performance of the package and torque strength of the cap are qualified, other indexes, including sealing strength and barrier property/permeation, should be evaluated, so as to guarantee shelf-life and properness for usage. For more information, please visit www.labthinkinternational.com.cn

Labthink’s Customer Solutions for Solar Back Sheet

Solar energy is inexhaustible and the cleanest source on earth. In one hour the sun delivers as much energy to the earth's surface as mankind consumes in one year. Solar energy is clean, sustainable, globally available, and does not harm the environment.

What is Solar Back Sheet (PV Back Sheet)?

The solar cell back sheet is the outermost layer of the PV module. The PV back sheet is designed to protect the inner components of the module, specifically the photovoltaic cells and electrical components from external stresses as well as act as an electric insulator. In order to accomplish this, the solar back sheet must be a robust construction, typically a three layer laminate, and have high dielectric properties.

Properties of Solar Back Sheet

• UV resistance
• Moisture barrier
• Mechanical properties
• Strength and durability
• Resistance to weathering
• Electrical insulation
• UL recognized

Labthink Customer Solutions for Solar Back Sheet

Moisture Barrier Property

Basically, solar back sheet is an encapsulate material which consists of fluoride and polyester film. How to determine the Moisture Barrier property of this kind of laminated films? ISO 15106 Plastics – Film and Sheeting – Determination of Water Vapour Transmission Rate, ASTM F1249 Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor and ASTM E96 Water Vapor Transmission of materials by Cupping Method.

   Based on these international standards, Labthink designed the water vapor transmission rate testing systems based on different testing method, cup method, infrared Detection Method and Electronic Detection method.  Labthink Instruments Company is professional in testing instruments of plastic film and laminated films with wide testing range and high testing accuracy.

 Mechanical Properties

  A qualified solar back sheet should have proper thickness and tensile strength. Mechanical Contacting Method thickness tester will help you get a high precise testing result at 0.1 micron accuracy. That will ensure the solar module quality in an extended degree.

  As we all know, universal testing machine in the market are most for the high rigid material, such as steel. Few manufacturers are focusing on the testing machine in flexible packaging fields. But Labthink is right focusing on the testing of flexible packaging. Labthink Tensile testers are professional designed for plastic films and laminated films with test range up to 500N and testing accuracy better than 0.5% of reading value.

Sealing Performance Test of Medical Plastic Bottle

Owing to its light weight, high strength, solid structure and excellent sealing characteristics, as well as moisture-proof and cleanliness performances, plastic bottle has found its wide applications in packing oral pills or liquid medicine. Moreover, medical plastic bottle coincides with the special packaging requirements for medicines and can be directly filled without cleaning or drying. In order to avoid the influences of light, heat and oxidization, etc., pharmaceuticals need bottles with excellent sealing performances, so that damp or deterioration will not occur during their validity period. Thus, it has been clearly stipulated in the relevant standards for the sealing performance of medical plastic bottles, which is a key index for manufacturers. Hereinafter, this article is to briefly introduce the sealing performance test of medical plastic bottle with Labthink MFY-01 Leak Tester.  

Sealing performance is referred to the sealing reliability of medical plastic bottle. Through sealing performance test, sealing integrity of the whole package could be guaranteed. Thus, excellent sealing performance of medical plastic bottle is a guarantee against moisture or deterioration during validity. It has been regulated in relevant national standards as follows: take a certain amount of medical plastic bottles, and fill each bottle with some glass balls. Then, tighten the closures of the bottles. The torque forces are listed below:

Diameter of closure (mm)	Torque Force (N· cm)
15～22	59～78
23～48	98～118
49～70	147～176

Then, submerge the bottle specimen into the water prefilled in the container with vacuum device, and vacuumize the test chamber to the vacuum degree of less than 27kPa and keep it for 2 minutes, during which no water should enter into the bottle, or no bubbles should be observed.

The working principle of Labthink MFY-01 Leak Tester is as follows: submerge the specimen into water and vacuumize the test chamber to form the pressure difference between the inside and outside of the specimen. Observe leakage of the specimen and how the specimen expands and restores to its original shape after vacuum released to determine the sealing performance of it. Labthink MFY-01 is fully automatic, easy to operate and user friendly; no more manual operation is needed besides inputting pressure value and duration. The above testing method is by visual observation which provides a qualitative determination. For quantitative determination of sealing and leakage property, the seal tester with positive pressure method should be used, e.g. Labthink LSSD-01 Leak and Seal Strength Detector.

Besides the sealing performance, more indexes such as oxygen permeability and water permeability, etc. need to be tested for medical plastic bottle to guarantee the shelf life. For more information of other related testing instruments, please visit www.labthinkinternational.com.cn. 

Did You Really Seal Your Blister Packaging - A Seal Integrity Testing Method for Blister Packaging

[Abstract] As blister packages for pharmaceutical drugs become more popular because of their many benefits, such as protecting drugs over long shelf-life, portability, and being tamper resistant. All of these benefits are based on that the blister packages are sealed well. But did you really seal your blister packaging? Do you know how to identify if your blister packages are sealed well? This article will introduce a simple and precise seal integrity testing method for blister packaging.
[Keywords] Blister Packages, Blister packaging, sealing Performance of blister packaging, Seal integrity testing, Seal integrity testing method

As blister packages for pharmaceutical drugs become more popular because of their many benefits, such as protecting drugs over long shelf-life, portability, and being tamper resistant. For a quality and process engineer, the common characteristics of a blister package provide a challenge. The good news is that blister packaging lines should never require 100% testing, as the process can be controlled in ways such that random defects do not occur. But laboratory tests are indispensable.

One of essential characteristic of blister package is seal integrity. It is the primary characteristic of blister packaging as a protection of drugs. Now, manufacturers can use a test instrument, like the Labthink MFY-01 Leak tester, to identify if their blister packages are sealed perfectly in laboratory. This is an automotive, easy-operated and user-friendly instrument.

Current Standard
The current industry standard for blister packaging leak test is bubble emission method, which is a gross leak testing method. In this method, submerge the blister package spcimen in an immersion fluid in a vacuum chamber, and then evacuate the vacuum chamber to form differential pressure between the inside and outside of blister package specimen. The leakage property could be obtained by observing the steady progression of bubbles from the specimen and how the specimen expands and restores to its original shape after vacuum release.

Quality Control for Blister Packaging - Permeability characteristics of Blister Packaging

[Abstract] As blister packages for pharmaceutical drugs become more popular because of their many benefits, such as protecting drugs over long shelf-life, portability, and being tamper resistant. For shelf life, blister packaging provides a barrier protection against contamination, particularly water vapour and oxygen. To control the quality of blister packaging and identify proper shelf life of pharmaceutical drugs, we need have knowledge of permeability characteristics of blister packaging. 
[Keywords] Blister packaging, permeability characteristics, oxygen barrier property, water vapor barrier property, Labthink, oxygen transmission rate, water vapor transmission rate tester

Blister packaging plays an important role especially for oral- and solid-dosage forms because of their many benefits, such as portability, being tamper resistance, greater efficiency, cost reduction and protecting drugs over long shelf-life. 

Pharmaceutical substances are getting more and more sophisticated, and also tend to get more and more sensitive to environmental influences like the attack of moisture and oxygen. The exposition of tablets and capsules to oxygen and/or moisture can have serious effects:

• Softening and disaggregation (mechanical corrosion)
• Chemical hydrolysis of the active ingredients (decrease of potency and/or forming of toxic compounds)
• Oxidation of the active ingredients (decrease of potency and/or forming of toxic compounds)
• Worst case, fatality can be the result of missing medication or decomposition of the product. 

To avoid or reduce such negative influences, the drugs must be protected by an effective barrier packaging. The first step in finding blister packaging solutions is to find out what you need. Evaluate your product to see how much protection is necessary. 

Water Vapor Transmission Rate 
Water Vapor Transmission rate is a measure of the passage of water vapor through a membrane. It is the rate of water vapor transmission per unit area per unit of vapor pressure differential under test conditions. It is an index of the ability of materials barrier water vapor. Higher water vapor transmission rate, poorer water vapor barrier property, shorter shelf life of products

Oxygen Transmission rate 
Oxygen Transmission Rate (OTR) is the steady state rate at which oxygen gas permeates through a film at specified conditions of temperature and relative humidity. Value is expressed in cc/100 in2/24 hr in US standard units and cc/m2/24 hrs. in metric (or SI) units. It usually depends on the type of material, pressure, temperature and thickness of materials. Same as water vapor transmission rate, oxygen transmission rate is also an index of the ability of materials barrier oxygen. 

Water Vapor & Oxygen Transmission Rate Measurement 
Before choosing your blister packaging materials or find blister packaging barrier solutions, you need to know what is the water vapor transmission rate (if the pharmaceutical drugs are sensitive to water vapor) and oxygen transmission rate (when drugs are sensitive against oxygen), then evaluate your product to see how much protection is necessary.

Oxygen Transmission Rate Testing Method 
Current testing method for oxygen transmission rate is equal pressure method, also known as Coulometric method. Usually, there are two chambers in this testing method. One chamber contains oxygen or air and the other chamber is slowly purged by a stream of nitrogen. Due to the concentration difference between the two chambers, oxygen molecules permeate through the specimen into the nitrogen side and are taken to the coulometric sensor where it produces corresponding amount of electrical signals. The oxygen transmission rate is then obtained by analyzing and calculating the signals. 

Water Vapor Transmission Rate Testing Method 
Currently, there are several testing methods for water vapor transmission rate testing, such as cup method, infrared sensor method, humidity sensor method and electrolytic sensor method. The most used method is wet cup method described by ASTM E96. Under a certain test temperature and humidity difference, measuring the weight changes of the test dish in different time, water vapor transmission rate and other parameters can be obtained.

We recommended you Labthink water vapor transmission rate testers or oxygen transmission rate testers, they can give you an accurate testing data for your blister packaging materials or finished blister packages. You can get all the instruments based on different testing method according your requirement from Labthink. The company is famous with their professional and high accuracy in the testing industry. You can visit their website www.labthinkinternational.com.cn for more information.