ASTM F 1980 All Your Questions Answered Here

 

QRA INTERNATIONAL 

INCORPORATED 2003 (SINGAPORE)

PROVIDING BIOMEDICAL AGING TEST SERVICES FOR OVER 15 YEARS

1. What is a Medical Device ? 

Medical devices are an article, instrument, apparatus or machine that is used in the      prevention, diagnosis or treatment of illnesses or diseases. They can be used for detecting, measuring, restoring, correcting or modifying the structure of the body for some health benefit.

Examples of Medical Devices

a) Contact Lenses

b) Blood Pressure Monitors

c) Hearing Aids

d) Heart Pacemakers

e) Tooth implants

    2. What is ASTM F1980  ? 

   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)

Shelf Life Test is then conducted to benchmark the product. Essentally it is to keep the product at the ambient temperature and humidity conditions for the entire duration of the product's useful life. This may be 3 years, 5 years or even 8 years. 

If the manufacturer wishes to sell his products into the world's largest market for medical devices, the USA, it needs to have its final products tested and passed according to ASTM F1980 - 21. 

In Europe it is known as the ISO 11607 

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

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

The need for controlled humidity should be based on the characterization data of the materials used in the medical device, it's packaging, and the long term storage condition.

4. What is the 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. ASTM F1980 specifically evaluates the aging process along with its package and how it impacts sterility and shelf-life. 

Accelerated aging therefore simulates these conditions by exposing the materials to elevated temperatures for shorter periods of time to represent an equivalent real time shelf life duration,

F1980 testing offers valuable safety and performance insights to manufacturers. 

With a greater understanding of the aging process on a product and its package system as the result of testing, manufacturers can 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

5. 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 'age' or 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 'age' in 4.5 months.

Therefore for a product with a shelf life of 3 years ; storage at 25 C 

a) Storage at 35 C  ; RH at 50 % RH  Aging Test Duration : 18 months

b) Storage at 45 C ; RH at 50% RH   Aging Test Duration : 9 months

c) Storage at 55 C ; RH at 50 % RH  Aging Test Duration : 4.5  months

QRA INTERNATIONAL offers Accelerated Aging Tests and Shelf Life Tests at most competitive prices internationally. Its 2 Labs with 20 Test Chambers are there running daily 24 hours a day, 7 days a week for your peace of mind.

We provide the following for a flat inexpensive fee. 

a) Monthly aging tests using top quality chambers from Germany, S.Korea, China        and Singapore. Test Durations : 4.5 months up to 60 months. 

b) Regular Test Reports Monthly, at start of test and at end of test.

c) Calibration Reports according to ISO 17025 (SINGLAS) for each test chamber prior to test.

d) DHL collection and delivery anywhere in the world 24 / 7.

QRA Lab 2 at 7 Perahu Road

Singapore 718 836

6. 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 (ASTM F 1980 -16)

2.    Humidity (F1980 - 21)

3.   Quantity of product testing samples (for 90% confidence and 90% reliability)

7.  What do I do after the Accelerated Aging and Shelf Life Tests ? 

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.

7.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. Westpak'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

8. 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, we recommend either 50% rH to 60% rH to be used.

The humidity aspect of the aging should also be documented.

QRA INTERNATIONAL can assist you in this with all our reports clearly stating the parameters controlled and any deviation of these set parameters.

9. 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

10. Can You Recommend the Test Protocols for my product to test under ASTM F 1980 and or ISO 11607 ? 

Yes We Can. Our recommendations will be based on your company's unique product, expected shelf life and how much you value your brand.We have decades of experience at our Labs to guide you along your way to brand excellence and reliability.  

Contact us by email at :

                      qrasales@qra.com.sg

                           mark@qra.com.sg

        Website :    www.qra.com.sg

Hypoxia Talk - Co Hosted by QRA International Pte Ltd.

 

QRA International is proud to be the co-host of this once in a decade seminar called Hypoxic Talk. The speaker Prof Julien Periard is the Deputy Director for the Research Institute for Sport and Research. Faculty of Health.University of Canberra.

Hypoxic or Hypoxia is the use of low oxygen atmosphere conditions to improve the body's physiology to enhance its performance. It must be used in conjunction with a proper nutrition and sports science methodology for maximum benefits.

Uses of Hypoxia to enhance performance can be achieved by

a) Hypoxic Generators.

b) Hypoxic Rooms

 

For details, please sign up in the attached QR Code and we hope to see you there. !! 

1960s - 1970s Pix from Those Days

 

The Lau family from my Mum's side. 1969

The never go back days are the days which were the most carefree and fun. Life was simpler, days were unending, and Singapore was populated with far less people than the 6 million now. I would hazard a guess that in those days of the late 1960s till the early 1970s, the population of Singapore was no more than 3 million. 

The picture above was taken by the Kodak instamatic camera which my Papa owned, so the clarity of the pictures weren't as good. The family above is the Lau family. My Mum's younger sister Mina, married Mr. Lau or Uncle Lau and the picture above shows my cousins from left

Wendy, (some unnamed girl), May, Uncle Lau and Angela.  

The Phoon family from my Mum's Side. 1969

Coming up the road of 6 Adis Road, is the Phoon family with my Mum Anna dressed in green.

From left is my Uncle Phoon, Lorraine, Rick, Mum Anna and Aunty Mona. Our bungalow house was set slightly on higher ground along Adis Road, and at the end of Adis Road was the mansion owned by the business magnate Eu Tong Sen. 

Me in 1963. 

The picture above is me, on all fours. I guess this picture was taken early to mid 1963.

Birthday Party 1969

Mum Anna and John (4 y.o.)

The dates are approximate, as I have no detailed records of when they were taken place. I only know that these are birthday parties held in our house at 6 Adis Road S'pore 9. I presumed it must have been either John's or my birthday and our relatives normally would get invited by my Mum Anna. She is the big sister to the 3 younger sisters Dona, Mina, Mona and  and 1 youngest brother David. 

 Neighbourhood kids playing on the swings and roundabout. We also had a slide in our garden.

I was a playful kid, that is without a doubt. A ruffian

I loved to read in bed, and my eyesight deteriorated so bad, that I had to wear glasses in Primary 3 to see the blackboard. I recall distinctly in Primary 3 when the nurses from MOH came to check on our eyesight, I called out the letters 'any old how' and the nurse yelled at me "don't bluff ! don't bluff !".

I still wear contact lenses till this day and my  eyesight is severly myopic and with aestigmatism.  

The 1960s and 1970s Days Story 2. Catching Spiders

 

For me and my generation, our ideal times of our lives were most likely the ones when we were in our pre teens and teenage days. There can only be one word to describe those 'never going back to those days again' world. A world without  Smartphones, Netflix, Cyberbullying, Scams Impersonation of police and immigration officers and Kpop world domination.

In one word, "carefree" 

Of course if I had a time machine, and I could transport myself to the late 1960s, the first thing I would do I would go 'home' to 6 Adis Road. The bungalow where I grew from an infant till I was 16 years of age.

I would hug and kiss my Mum and Papa that would be the first thing I would do and just talk about my life without them now that they are gone for over 14 and 13 years respectively from the conscious world. Just catching up with them would take at least 3 - 4 days of talking.

Its just a whimsical wish I guess

To grow up in that world that was Singapore, in the late 1960s to mid 1970s - a full 10 years was nothing short of magical in hindsight. Singapore was 3rd world, meaning, our per capita GDP was probably on par with most African nations and below that of Burma (Myanmar), Sri Lanka and the Philippines. We collectively were a poor nation with no natural resources and only a paltry population of slightly over 2.5 million then.  

We had zero (yes zero) homework. That was beautiful for lazy and playful kids such as my brother and I. We did all we had to do in class. So, when we went home, we ate our lunch (on the odd occasion) or had lunch at the tuck shop before we headed home. Then it was play outside all day. 

We alternated between morning session and afternoon session in school. Classes were only half a day long. We would normally return home by 2 pm. After a quick shower, we would then make a beeline outside to the large garden of our bungalow and meet with the neighbourhood kids. 

The games my brother and I played with our neighbours were (and they are long gone I assure you) were (not exhaustive) :

- marbles or Go Li

- general fighting and soldier games.

- catching and fighting spiders

- Dog and Bone

- Flying Kites

- Tin Can Telephones. 

Let me elaborate on Catching Spiders and Tin Can Telephones.

1. Catching and fighting spiders.

Only people who lived their childhood days from the late 50s to the early 70s would identify with this really fun activity. Basically, we would go to plants and small shrubs and look closely at the leaves. If we spot 2 leaves which happen to be 'glue stuck' together, it is likely that a spider has created a nest between those 2 leaves.

Bam ! with our cupped hands we would catch the spider and gingerly place our prized catch into an empty matchbox. We would line the bottom of that matchbox with leaves and some dead or alive ants as food for the spider.

Once we had our 'champion prize fighter', we would saunter to whoever had another spider and then place our prize fighter on the flat surface and like a natural reflex, the spider would eye the other competitor and raise its front 2 legs like pincers of a crab.

The 2 spiders would fight with ferocity and the 2 pairs of 2 legs would be in full flight. It was and still gives me a thrill to watch nature in all its brutal glory.

One spider would back off and run away and that was the 'loser'.

2. Tin Can Telephones.

We had a lot of fun also (even though we didn't know the physics behind the fact). We would source 2 old condensed milk cans, One end would be open (to take out all the contents) and we would clean both cans with soap and water. On the sealed end, we would use a sharp knife to create a small hole on that side. 

We then strung a piece of string between 2 cans and created our own 'telephone'. Apparently the sound of your voice from one can is transmitted by air waves, and some of the sound gets converted to solid vibration mini waves into the string and transmitted to the other can (max is I believe 6 feet away). Upon reaching the next can, the empty can amplifies the sound and you 'hear' the voice of your friend.

I cannot vouch that this 'phone system' actually works, as 6 feet is near enough to hear your friend when we speaks or even shouts !

 

  

 

    

A Smooth Sea Never made a Skilled Sailor - Franklin D Roosevelt

 

This is so apt. For me at this stage in life, I am charting in open seas. There are times when the sea is smooth and everything is 'hunky dory' (to pen a phrase from a friend). Never take wealth, health, family and the economic situation for granted. Not for a minute. 

Everybody can put up a brave face and smile for the social media. The ones truly happy are the people who have their goals laid out clearly from young and met (at least 90% of it anyway).

Broadly they encompass 

1. Financial independence 

2. Some reserves for a rainy day (at least 2 years or 24 months)

3. Good Health mentally and physically with mobility

4. Strong relations with family and some friends.

5. Relevance to society or the environment around them. 

My small business is in steady waters. However, in an instant there may be a giant gale coming around the horizon and a hurricane or major storm is just around the corner. We have to be prepared for it or we are history.

I was reminded this morning of the quote by the founder of the Scout Movement worldwide 

"Be Prepared"

I will add my additional quote to this 

"Be Prepared and Take Appropriate Action"