ASTM F 1980 Accelerated Aging of Sterile Barrier Systems for Medical Devices - 10 of Your Questions Answered

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)

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. 

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. 

We have a fleet of 20 Test Chambers running 24 / 7 to serve our many clients internationally.

We provide the following for a flat inexpensive fee. 

a) Monthly aging tests using top quality chambers from Germany, Italy and Singapore

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.

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 products to comply with the new F1980-21 ?

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

Mentally Strong People Do these 18 Things - the Next 6

 

In Chiangmai Old Town in 2006

1. Practice Realistic Optimism - Be True to Yourself.

 Unless you live on a mountain top or alone, and report to no one, you will come across many people in your life, whom you will interact with, many on a regular basis. Hence, you will have bosses, clients, vendors, people you buy and sell things to and from, people whom are related to you by blood, school, swimming club, work, social networks, and places of worship.

You will be faced with many challenges day in and day out, week in and week out. If you tackle these challenges head on, you will realise some are too big for you to take on yourself, and you need to take stock and realise either to 1. fight 2. take flight and 3. be frightened and stay rooted like deer caught in headlights of an oncoming car in a quiet country road.

Hence, while it is so important to have an optimist mindset, that mindset MUST be tempered in realism and not your personal delusions of grandeur. Do need spend needless money to buy a fancy car, watch or house to impress meaningless people about how 'good' or 'great' your life is.

No one bothers to appreciate your 'success'. Only you will be the final arbiter of your own 'success'. It doesn't matter if you live in a small flat, take public transport or live in a huge mansion and drive a Bentley.

What matters is that you have done good, been a good provider to your family and community and hurt no one.

Be realistic in setting and chasing after your goals. That way you will not be disappointed if and when (90% of us will face this) you miss these goals. Such is life. 

2. Tolerate Discomfort

This is a tough on9e, but mentally strong people can shut out all the pain, distractions, the negative and hurtful comments, the disuasions, the naysayers, the jealous bystanders, the multitude of people who would love to see you fail. That is discomfort on a daily basis.

Learn to Tolerate it, but Practice Optimistic Realism (see point 1 above)

When you do succeed, 100% of these so called naysayers will professed to have supported you. 

Feel free to drop them from your friends list :)

3. Modify Unhealthy Beliefs

Weed out all thoughts of failure. When faced with defeat, the strong still die fighting. They only give up when the chance to fight another day and come back stronger is much better than depleting your resources 100% today with no chance of returning.

4. Accept Challenges 

This is self explainatory. If you do not challenge yourself what are you living for ? 

                                                           Rialto Bridge 10th Dec 2023 

5. Practice Perseverence

Only those who persevere will win something in the end. My mates in armoured artillery are prime examples of mentally strong people who though they may not have been the most physically strong, we all were able to take mental anguish, pain and rampant bullying during those tough training days.

I am glad to say that all of us NCOs are doing pretty well now.

6. Set Healthy Boundaries 

This ties in to having a good mental discipline to stop punishing our bodies and minds. Insofar as eating excessively, smoking, exercise regularly and doing good we must remind ourselves, the price we pay for overextending ourselves in any of the above will only cause our downfall at the end.

Carpe Diem my readers. 

18 things Mentally Strong People Do ; Here are the first 6

These ideas are not mine, originally. These are taken from Mr. Steve Wohlenhaus of Weatherology Inc. (picture below) who is a motivational speaker and someone whom I share a great deal of ideals and values with. So here is the first 6, with my own life experiences thrown in. 

 1. Practice Gratitude 

This is very much like the mindset of the self assured and strong person you are or whom you want to be. If you have received help, do show thankfulness and gratitude to whoever (it can even be to God) has made you arrive at  your current situation.

I am grateful to many people, spiritual and on this earth. So I thank them in my quiet time and also in person, or do things to show my thankfulness.

2.  Learn from Mistakes

Never let ego get the better of you. The self (or Id) is a concept which some people call 'face'. Of course it is never nice to be humiliated. I've made many mistakes in my life. However, I believe I am luckier than most. I remind myself that at my age, I am blessed with so many things like my good health, my family and 2 good sons, a big roof over my head, transportation, enough food, a very safe and secure high standard of living and working environment and strong relationships with friends from many around the world, from school, life and social circles. 

I get to travel for work and relax many times a year,    

There are some people who are much better off and many many others who are worse off than where I am today,  So its useless to compare on material terms. Just aim to do better in things than what you did 1, 2 , 5 years before.  Things like :

1. analytical and logical thinking

2. compassion and empathy for your neighbour

3.  deciding on important issues correctly and fairly.

Coming back to the point of Mistakes, if you make them in private. 

a) accept them - even when they are pointed out to you from the most unexpected source.

b) realise when and why you made them

c) Focus on being a better person and pledge never to repeat them.

If your mistakes are exposed in public. That is 100 times more painful, but follow a) to c) and add d)

d) Ask God for peace in your heart. 

e) Sleep easy. In 5 years no one remembers it anyway,

f) Pray for a thicker skin. :)

3. Take Calculated Risks

Easier said than done. Get out of your comfort zone. Be used to being uncomfortable. That is the only way you grow and accomplish anything which you will one day look back and be proud of - your accomplishments.

They are not your accomplishments if you never put effort, focus,energy, blood, sweat, money and tears for.  

4. Focus on the things that can be controlled

There is so much bizarre and turbulent news of late with multiple wars in the Middle East, Ukraine and the threat of war hanging over North Asia, there is nothing much you can do ; the only thing you can control is your emotions and try to double down and prepare for a cold hard _____ number of years. Only the strongest minded will see through the hardest of times, with a little bit of luck. 

5. View failure as an opportunity for growth

Again easier said than done. Keep Calm, Move ahead with my life and business plans, save for the rainy days, invest in long term assets, keep healthy, strengthen relationships within family and close friends and stay focussed on doing the best I can. 

6. Accepting full responsibility of our own lives.

At this stage in my life. I can say that I accept my failings as they are and pledge to do better tomorrow. I do not blame anything or anyone for my lousy situation, and try my 110% to make tomorrow a better day than today.

I will move forward, try, aim high, fail, try again and again. 

That is way of being Mentally Strong. 

Karate Training - Cross Training necessary for Flexibility

 

This Sunday's class is no different from each Sunday class. We have about 20 to 25 regular trainees who come every week and it is a mixed bag from all age groups, genders, and some nationalities.

I am happy to be the current Ken Shin Kai club President and with the guidance of Sensei Chia Kwek Fah (8th Dan Hanshi), we hope ton take part in some National tournament in the near future. We have 6 potential 'players' mainly from the young age group who we hope will step up to represent out club this year and do us proud. I have been practising karate for 22 years and currently hold the rank of Black Belt Dan 3. The reason I chose karate is that a lot of the movements emphasise balance, flexibility and strength which complements my other group of muscles utilised when I run long distance, which is namely balance, strength and endurance. It is the perfect foil for CROSS TRAINING. 

While my body feels its age, the old saying that 'age is just a number' well I can refute that.  

When you reach a certain age, and everything starts to stiffen, ache, and it takes much longer to recover.It was never like that in my 20s, 30s, and 40s. I used to run 10 - 14K PER DAY in the mornings EACH DAY for 5 days per week and after each run, I would go home, wash up and prepare for work THAT SAME DAY. This ritual would be repeated day in day out for years.

Hence, the body recovery for me as an example in the 20s, 30s and 40s are much FASTER than what I am experiencing NOW. Age slows everything down and from recovery, reflexes, and muscle strength diminishes - if not kept in check by CONTINUING to maintain or UP THE FREQUENCY OF EXERCISE EACH WEEK.  

Just remember, the human body is a quite like a  mechanical machine, while cells replicate and are formed daily, the bone structure and muscles will wither over time, so parts replacement is necessary - if there are replacment parts. Intraocular lenses for eyes, teeth implants and titanium plates are but 3 miracles that medical technology has advanced over the last 5 - 6 decades resulting in many people living well into their 90s and possibly 100s years of age - IF they have taken good care of their bodies and minds. 

Tinto - A Revisit 13th April 2024

 

Tosta Ramona with Anchovies and Burata Cheese 

Yesterday 13th April, we celebrated my wife's birthday at Tinto in Dempsey Road. We had eaten there once last year in June 2023 when my other son, Andrew was back in Singapore for a holiday.

When we arrived, the main dining hall was reserved for a private function (someone's going away party) and we were ushered into the back dining room promptly. We ordered exactly the same dishes save the suckling pig and the Gazpacho (cold soup) as there were only 3 of us yesterday compared to 9 months ago.

Sadly, the dishes turned out rather bland compared to the first dining experience and although the standard is still very good, there was a suspicion that the kitchen had pre made these dishes in advance and kept them warm - as there was a big function in the main dining hall and hence the kitchen would be overworked.

This is only our hunch or guess.

Anyway, here are the 3 better dishes which I would give on the average 4.5 stars out of 5.

Tosta Ramona with Anchovies and Burata Cheese - Tapas

The toast is very crunchy and the anchovies are fresh. The cheese is just right and there is a hint of tomato paste below the anchovies.

Much recommended.

Gambas Al Ajillio ; 

Pan fried prawns, garlic and chilli chips with tomato puree

Gambas Al Ajillio - Tapas

My wife's favourite. The prawns are fresh and the garlic oil is oh so tasty. The fried garlic chips are just right. 

Highly Recommended 

Chicken and Pork Paella 

Chicken and Pork Paella - Main Course

The paella was tasty and there were ample portions of chicken and pork, mixed with cheese, zucchini, baby brocolli and rosemary herbs. 

Highly recommended. 

Accelerated Aging for Biomedical Devices IQ OQ and PQ

 

For people in Quality Assurance in Biomedical,Pharmaceutical and Medicinal Foods, it is imperative to have the following ready for presentation especially during audit for a Good Manufacturing Practice factory.

IQ, OQ and PQ refers to the 3 activities that must be performed on test equipment and machines as part of the validation of manufacturing processes.

Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) documentation will be provided and consultancy given by our friendly sales specialists whenever any environmental chamber is purchased from QRA INTERNATIONAL.

These documents will be necessary for the manufacturer to fully comply when the audit checks are carried out by the relavent health authorities  particularly when GMP certification and audit periods come around.

Contact QRA INTERNATIONAL PTE LTD for more information

www.qra.com.sg

Email : mark@qra.com.sg

            qrasales@qra.com.sg

We can help you get certified for your biomedical and pharmaceutical grade products.