Compliance with Environmental Conditions and Strength Tests

Compliance with Environmental Conditions and Strength Tests

EUROLAB Laboratory works with specially designed climate cabinets and sensitive temperature / humidity chambers and data collection equipment. These high quality and reliable chambers are fully programmable for environmental cycle testing, including

  • Thermal Performance of Packaging
  • Product Quality and Reliability
  • Product life
  • Drug Stability protocols
  • Forced Decay Studies
  • Product Resistance to Environmental Conditions

Thermal cycling tests are important for product and package development to ensure that extreme effects of climatic conditions do not impair the efficacy of pharmaceutical products; packaging protects products from temperature and humidity trips; and the packaging itself does not deteriorate under extreme thermal changes in climatic conditions (eg dry desert, tropical, etc.).

For example; The chambers use it specifically for cold chain packaging to verify that they are designed and designed for the shipping of pharmaceutical products.

What is an environmental simulation test? Simply put, simulated test environments are about making products for real-world use. This is achieved through the testing experience and performance data as early as possible during the lifetime of the products. Simulated environmental tests generally involve creating artificial environments for test items to determine their expected flexibility to expected environments.

A classic example of environmental simulation tests includes test components for satellites. Components designed for use in satellites encounter repeated changes between extreme temperatures several times over the 24 hour period. When the components are in direct sunlight, they can reach temperatures up to 120 ° C. When they are in the shade they can cool down to -100 ° C. A satellite that rotates about 14 times a day on earth will experience a thermal cycle over 50.000 for a lifetime between these extremes! Cycling between extremes tends to change material properties and fatigue equipment early.

Accelerated aging protocols are performed in EUROLAB Air Conditioning chambers to give a shelf life range for medical devices. Studies are shown below:

 Climatic Description

Temperature range

Climate Environment Chambers for Large Projects

30 ° C to + 60 ° C + 23 ° C ± 1 ° C /% 50 RH ±% 2

Access and Bench Top Rooms for development work

-70 ° C to + 190 ° C

ICH Refrigerated Long Term Storage

+ 5 ° C ± 3 ° C

ICH Long Term / Accelerated (Refrigerated)

+ 25 ° C ± 2 ° C /% 60 RH ± 5%

ICH Intermediate (Regions I, II, III and IVa)

+ 30 ° C ± 2 ° C /% 65 RH ± 5%

ICH Long Term (Region IVb)

+ 30 ° C ± 2 ° C /% 75 RH ± 5%

ICH Accelerated (Regions I-IV)

+ 40 ° C ± 2 ° C /% 75 RH ± 5%

Long Term (Frozen)

-20 ° C ± 5 ° C ICH

Cryogenic Storage

-70 ° C to -90 ° C

 Packaging and Packaging Tests

  • ASTM and ISTA Distribution Test
  • Pharmaceutical Package Testing
  • Consumer Product Testing
  • Shelf Life and Accelerated Aging Test
  • Environmental air conditioning
  • Packaging Materials Testing
  • Package Integrity Test
  • Package Strength Test
  • Package Labeling
  • Environmental testing
  • Forced Distortion Study

Industrial Tests

Pharmaceutical / Drug Stability / Cold Chain Package

  • PDA TR # 53 Stability Test to Support Distribution of New Pharmaceutical Products.
  • PDA EN # 39 Guidance for Temperature Controlled Medical Products: Maintaining the Quality of Temperature Sensitive Medical Products over the Transportation Environment
  • ICH Q1C Stability Test for New Dosage Forms
  • Parcel Delivery System ISTA Standard 20 / 7E Test Standard for Thermal Carrier Packaging Used in Shipment
  • ISTA 7D - Temperature Test for Transport Packaging

Medical Device Package

  • ASTM D 4332 Standard Practice for Conditioning Test Containers, Packages or Packaging Components
  • ASTM F 1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
  • Standard Practice for Climatic Stress of Packaging Systems for ASTM F 2825 Single Carton Delivery
  • ISO 11607 Terminal sterilized packaging for medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

EUROLAB Lab is happy to help customers better understand their testing requirements, available testing options and how to execute packaging validation projects on time and on budget. Do you have a question about Pack Test?

Benefits of Environmental Tests

When environmental testing is not required by contract or law, the greatest benefits are achieved by improving product reliability and reducing the risks associated with product development. But at what cost?

In the case of environmental testing, some costs can be measured and others cannot. Measurable costs are the estimated cost of environmental testing against the total cost of recalls, warranty claims, loss of productivity, and other damage to defective products. These are the values ​​that can be measured from the available data. The benefits of environmental testing are based on business dynamics that do not exist before an environmental testing program is implemented, and competitors are unlikely to share any internal data on these issues.

The best way to see if a simulated environment testing program is financially feasible is to see if the estimated test cost is acceptably lower than the total error cost. Simulated environmental testing poses a negligible risk during production life and reduces the overall risk.

Dynamic Testing

Dynamic testing is a broad category that includes testing elements against acceleration, vibration, fatigue, shock, falling etc. The basic idea is to apply various types of physical stress to test whether they can withstand substances. Apart from shaking a truck around a centrifuge, we can simulate stresses from rocket launches, rapid flight maneuvers, collisions, pressure changes, and more. We can even run special tests for special applications. The F150 centrifugal test is not a typical test, but we created the test so that Ford could demonstrate the advertising rigidity of his truck. If you have specific needs for a particular test, we can work with you to find the ideal solution.

EMC / EMI Test

Over the years, electronic components have become smaller and more sensitive to electrical disturbances. Some types of electronic components are also sensitive to other types of radiation. At the same time, electronic components have been used for greater security and mission-critical applications. Therefore, electrical and electronic engineers need to pay special attention to ensure that their designs are durable and fault resistant to electromagnetic disturbances. At NTS, we routinely test electronic equipment to ensure that it meets operational standards for the expected environments. In addition, many types of electronic devices require tests to ensure that they do not emit unnecessary amounts of electromagnetic radiation. In this case, the aim is to prevent electronic equipment from interfering with the operation of other nearby electronic equipment. The FCC, DoD and other agencies all have relevant standards for such tests.

Materials and Chemical Tests

The best way to see if a material is suitable for the environment is to exaggerate the environmental conditions it will encounter in the given application and see how it changes its properties. In the case of testing satellite solar panels, the aim was to see how the solar panel materials withstand the repeated thermal cycle. Other environmental tests can measure corrosion or chemical resistance as well as UV exposure reactions. Another category of material and chemical testing involves testing the properties of dangerous substances. If a material is suspected to be dangerous, its properties must be quantified and approved to implement appropriate handling measures. Known dangerous goods must also be safely packaged for shipment. The only way to determine whether they are safe for shipment is to perform environmental testing. This means that the packets must be subjected to temperature changes, drops, impacts, vibrations and simulated altitude changes to ensure that nothing bad can happen during transport. NTS performs such tests routinely on lithium batteries, so they are considered safe for transport.

Other Types of Environmental Tests

Almost every type of test involves manipulating environmental factors to determine whether the product will perform satisfactorily. Environmental testing is a broad category. Environmental simulation tests include heat, pressure, humidity, humidity, UV exposure, weather exposure, etc. The changes may include and these environmental simulations may be performed in combination with any combination of dynamic and material testing.