Sunday, March 3, 2024

Accelerated Aging and Shelf Life Testing - according to ISO 11607

 

What is the meaning of 'shelf life' ?

Shelf-life testing demonstrates the ability of a packaging system to maintain sterile integrity and strength over a defined period of time, and is indicated by labelling the product with a use by or expiry date.

Shelf life is defined as the length of time that a product may be stored without becoming:

  • Unfit for use
  • Unfit for consumption
  • Unfit for sale



QRA operates 2 Labs with 20 test chambers running 24 hours 7 days a week 


What is accelerated aging?

Accelerated aging is an artificial procedure used for establishing the shelf life to estimate the useful lifespan of a product when actual lifespan data is unavailable in an expedited manner.

Accelerated aging is conducted by simulated exposure of the product to elevated temperatures and realistic relative humidity levels for the equivalent period claimed for product expiration. The provisional accelerated aging expiration date will remain until real time aging results are acquired.

Typical Accelerated Aging Temp and Humidity Conditions 

1. 55 C 50% RH

2. 60 C 50 % RH 

Typical Duration of Tests 

1. 18 months

2. 9 months

3. 4.5 months

What is Real Time aging?

Real time aging is a stability testing process used to provide real data to determine the shelf life and the effects of aging on materials over time. The packaged product is exposed to storage conditions such as temperature and relative humidity to determine its shelf life. These studies are typically carried out at ambient temperature between 25°C to 30°C.

Humidity is also controlled with settings of between 40 to 60% being the most common settings. 

How is accelerated aging calculated according to ASTM F1980 ?

Accelerated aging techniques are defined on the basis that the chemical reactions involved in the deterioration of materials follow the Arrhenius reaction rate. This states that a 10°C temperature increase results in approximately two times an increase in the rate of the aging process. The accelerated aging process is based on the relationship of temperature and reaction rate where an increase in temperature increases the reaction rate.

The level of relative humidity (RH), should be included at realistic levels. When controlling humidity during an accelerated aging study, it is suggested in the standard to use a realistic level between 45% RH and 55% RH unless there are documented reasons for using other humidity levels. If other levels are used, a rationale should be documented.

  • It is not recommended by the standard to age packaged products at temperatures above 60°C unless knowledge of the materials shows otherwise
  • The calculated duration is normally rounded up to the nearest whole day
  • Ambient temperature Real Time Temperature (TRT) is typically between  25°C to  30°C
  • The aging factor of 2.0 is the most common value but other levels between 1.8 – 2.5 may be used once sufficient knowledge of the materials are known and can be justified

Accelerated aging time formula calculation

Product temperature storage labelling considerations

Where a product is labeled with specific storage temperature range, the upper temperature listed should be used when calculating the accelerated aging duration. This is instead of the normal ambient temperature (TRT), which is typically 25°C or 30°C. If the labelled range is 15°C to 35°C, then the 35°C should be used as the ambient temperature TRT in the calculation.

Timepoints:

It is recommended that minimum of two shelf-life timepoints are used. This provides a backup if post aging tests do not meet acceptance criteria for a particular timepoint.

QRA offers a range of accelerated aging chambers, which can accommodate both large pallets and single shipping units.


Stability Testing

What are stability studies?

Stability studies are conducted to evaluate the quality of a pharmaceutical or drug product over time to evaluate the influence of various environmental factors such as temperature, humidity, and light. Typically, under accelerated conditions, this simulates the effects of long-term storage in a shorter period of time.

STERIS also offers stability testing capabilities in accordance with ICH guidelines for pharmaceutical manufacturers.

Conditions include:

  • 5°C
  • 30°C, 60% RH
  • 30°C, 65% RH
  • 30°C, 75% RH
  • 40°C, 75% RH

Interested ? Talk to the Experts  Contact

QRA International Pte Ltd. 

Website : www.qra.com.sg

Email    : mark@qra.com.sg

Tel        : (65) 6795 1486 




Friday, March 1, 2024

To be the 'Go To' Person or Place - Just Follow Qatar

 


At the Souq Waqif in Doha 2022

Just look at Doha now. Prior to 2022 FIFA World Cup, very few people had heard of the place let alone visited it.

They are now on everyone's lips in terms of world sports events. 

This did not come by chance.

This was all planned for the last 20 years ; Meticulously and engaging top people with lots of experience in events management of the grandest scale.

For an individual, it is simpler. In the following days and weeks I will show you how to boost your followers and popularity on several social media platforms.



Wednesday, February 28, 2024

ASTM F 1980 - 21 Standard for Accelerated Aging of Sterile Barrier Systems for Medical Devices. All your Questions Answered Here

 

            QRA has 2 state of the art Labs in Singapore equipped to test your     

                   medical devices from all customers WORLDWIDE.

            QRA' s current Clients are from Asia, Australia and United States of 

                                                     America. 

ASTM F1980 - 16 

Standard for Accelerated Aging of Sterile Barrier Systems for Medical Devices

ASTM F1980 is a test standard titled, "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices" is a testing procedure that is used to help with the assessment of the sterile integrity of a package and product designed for medical use.

In order to validate a product and package's Sterile Barrier System (SBS) over the intended storage shelf life, accelerated aging is conducted to evaluate a package and product's long term usability and efficacy. ASTM F1980 is a specific accelerated aging test protocol set forth by ASTM International (American Standards for Test and Measurement International)  

It is also advisable to benchmark the product with Shelf Life Test which is to keep the product at the ambient temperature and humidity conditions for the entire duration of the product's useful life.

In summary, 2 different catagories of tests will be carried out simultaneously 

1. Accelerated aging test at 55 C 50% for a 3 year shelf life product for 4. 5 months.

2. The 'control' shelf life test to be kept at the full 3 year or 36 months test.


ASTM F1980-21 replaced F1980-16 in December 2021. What changed?

The revisions'  change recommends that the use of controlled humidity during acceleratedaging be considered, findings documented, and used during testing if warranted


Purpose of ASTM F1980 

To function safely and effectively, medical devices must maintain their sterile integrity throughout their shelf-life. However, over time, the physical properties of the materials may degrade in certain environments and, as a result, may negatively impact the safety and efficacy of the product. Because they endure so many unique environments while being transported,used, and stored, 

Medical devices must undergo shelf life testing in addition to sterile integrity testing. Hence the 2 tests above must be run simultaneously. 


ASTM F1980 specifically evaluates the aging process of a product along with its package and how it impacts sterility and shelf-life. 

Acing tests simulate these conditions by exposing the materials to elevated temperatures for shorter periods of time to represent an equivalent real time shelf life duration. ASTM F1980 testing offers valuable safety and performance insights to manufacturers. 

With greater understanding of the aging process on a product and its package system as the result of testing, manufacturers can and do make more informed decisions regarding the handling, storing, and use of the product. Additionally, precise aging tests achieved by tight temperature tolerances offer enhanced assurance among regulatory agencies and consumers.



 
QRA Lab 1 at 21 Toh Guan Road East,

04 - 02 Toh Guan Centre

Singapore 608586

       12 Top Quality Environmental Chambers with Calibration and Full Reports 

                                     1st Class Service with Competitive Pricing Worldwide

Frequently Asked Questions :

What is the procedure for an accelerated aging test for medical devices?

In accelerated aging tests for medical devices, a material or Sterile Barrier System (SBS) is exposed to elevated temperatures for a condensed amount of time. By exposing the testing materials to more extreme conditions during a shorter time frame, researchers can evaluate how a product will age under normal conditions without waiting for the entire desired duration. Armed with this knowledge, manufacturers can determine shelf life, storage, in-use, and transportation parameters more accurately for their product.

Accelerated aging is a standard practice in the medical device industry for determining shelf life parameters by accelerating the effects of time on a Sterile Barrier System (SBS).


The accelerated aging process is based on the relationship between temperature and reaction rate, in which the reaction rate increases as the temperature rises. The Arrhenius Equation is the basic formula used for an accelerated aging test for medical devices is:

Accelerated Aging Time (AAT)= Desired Real Time (RT) divided by the Accelerated Aging

Factor (AAF)

ln summary

Every 10 C increase in ageing temperature shortens the AAT by half.

Therefore if you have a product whose expected shelf life is 3 years or 36 months, the device is expected to 'ageor experience :

>  for ambient storage 25 C ; keeping the product in a chamber at 35 C, the product is expected to 'age' in 18 months.

>   for ambient storage 25 C ; keeping the product in a chamber at 45 C, the product is expected to 'age' in 9 months.

>   for ambient storage 25 C ; keeping the product in a chamber at 55 C, the product is expected to 'agein 4.5 months.


NOTES

The calculated AAT is typically rounded up to the nearest whole day.

QRA does not recommend aging packaging materials at temperatures exceeding +65°C. Common Accelerated Aging temperatures (TAA) are +50°C, +55°C, and +60°C.

Ambient temperature (TRT) is typically between +20°C to +30°C. A temperature of +25°C is a more conservative approach.

The aging factor is typically between 1.8 2.5 with a value of 2.0 being the most common accepted value.

To perform ASTM F1980 accelerated aging tests for medical devices, the laboratory facility must identify the Q10 value of the testing sample. The Q10 temperature coefficient is a measure of how quickly a material system changes when the temperature is increased by +10 C.




QRA has 2 state of the art Labs in Singapore equipped to test your     

                   medical devices from all customers WORLDWIDE.

        QRA's current Clients are from Asia, Australia and United States of 

                                                     America.

 

                                             QRA Lab 2 at 7 Perahu Road

                                                  Singapore 718 836


What are some of the parameters for ASTM F1980 testing?

ASTM International sets forth specific test parameters to ensure consistent testing across different lab facilities. The basic parameters for ASTM F1980 include the following:

1.    Accelerated Aging Temperature

2.    Humidity (F1980 - 21)

3.   The quantity of product testing samples

After the Accelerated Aging Tests, it is advisable to send your medical products to

a)    Peel Test

b)    Bubble (full immersion) Test

to determine the Confidence and Reliability Levels. QRA can advise you on these matters.

Arrhenius Equation ; What is it ? Why is it Useful ?

Using the Arrhenius Equation, the TRT should accurately reflect the actual product storage and in-use conditions, generally between 20°C and 30°C.

Accelerated aging temperature should be identified prior to testing. This is done by having in-depth knowledge of your materials, product, and packaging. It is not recommended to exceed +65 °C.

The need for controlled humidity during accelerated aging should be identified prior to testing; if materials are subject to moisture degradation, 45% - 55% RH is suggested. This input should be determined with your material providers' assistance.

A Q10 factor needs to be determined, which involves testing materials at various temperatures and defining the differences in reaction rate for a 10° change in temperature. A typical Q10 factor used during testing is 2.

Accelerated aging factor should be specified using the following equation:

AAF = Q10 (TAA-TRT)/10

QRA's sales professionals can walk you through your product ageing test needs. 

What is the best temperature to use for an ASTM F1980 test?

The ASTM F1980 standard suggests using an accelerated aging temperature below 60°C. Aging your product at a greater temperature provides the advantage of a faster simulation of the aging interval, but this comes with risks for particular products and packaging materials. Medical devices are often engineered with delicate materials that may drastically change when exposed to temperatures exceeding +60°C. Finding out if your medical product or device may be adversely affected by long periods of high heat or low humidity is a good place to start when choosing the best accelerated aging temperature.

QRA's experts can help you define the ideal temperature parameters for your products and packaging.

Common Accelerated Aging Temperatures: 50 C, 55 C, 57 C or 60 C


Does the F1980-21 version require using controlled humidity during accelerated aging?

In short, humidity is not a required element of accelerated aging. The recent version suggests that humidity conditions in the aging study be defined before starting aging studies. If RH will not be controlled, the rationale for exclusion should be documented.

What is the best humidity level to use for accelerated aging?

Humidity usage is dependent on the materials used in your product and packaging, how moisture impacts them, and other environmental factors. If humidity during accelerated aging is to be controlled, 

How do you evaluate the ASTM F1980 test, post-aging?

After a testing sample has undergone the accelerated aging process, its physical properties and package integrity will be compared against various aging time points.

This includes as per ASTM F1886, 

1. Peel Testing

2. Bubble Test 

3. Dye Test

My products must comply with the new F1980-21 revision. What do you recommend?


Whether you have a released medical device or a new product in development, QRA sales experts can help. Our recommendations will be based on your company's unique product, expected shelf life and how much you value your brand.

Talk to The Experts. Talk to QRA 

Consultancy is at NO COST.

Quotations are Free and Prompt. Prices are Inxpensive.

Service is World Class. 

Please contact :  Email : mark@qra.com.sg

                            Email : qrasales@qra.com.sg

                           Website : www.qra.com.sg



QRA Vision Statement

  A Constant Reminder to myself and my readers of the reason why QRA is in existence.