ASTM F 1980 all your questions answered here in this post

 

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

Live High Train Low and Train High - the Science behind the Improved Results of our National Athletes

 

Internal View of Athletic Chamber supplied by QRA INTERNATIONAL  

Our national sprinter Ms. Shanti Pereira has made the front pages of the news these past few years by coming in 2nd in the women's 100 m sprint and attaining the gold medal in the recently concluded Asian Games (2023 edition) in Hangzhou China.

Kudos to her and her team of coaches, sports scientists, nutritionists and officials for reaching the pinnacle of her sport and has made her the current darling of Singapore sportsmen and women. The team behind her success is instrumental in ensuring that her performance is approaching world standard. There is also a whole depth of scientific work and sports preparation  for many months and even years to get her performance to world class level and as a result slash her 100 m and 200 m times by so much. All legal and employing the highest levels of science and technology, coaching techniques etc - it is worth it.  My humble opinion.    

Two particular pieces of equipment which I wish to highlight ; the Singapore Sports Institute offers hypoxic sleep rooms with O2 levels of 3000 m or 18.6% O2 per cubic metre of air. Normal sea levels have 20.9 or 20.8% of O2 per cubic metre of air. They also have an athletic chamber of approximately 70m3 size (which my company supplied in 2016) whereby the athletes can train from the various temperature and humidity ranges :

The Technology 

Temp : 0 to 50 C

Hum  : 20 - 95 % rH

O2    : Sea level or 0 m (20.9% O2) to 5000 m (16.5%) 

Additionally there are special components called : CO2 scrubbers which filter out (scrub) the CO2 from the air inside the chamber.

 

Fun Fact

People who are trapped in sealed enclosed spaces for long durations (freezer cold rooms for example)  die or faint from CO2 poisoning rather than from a lack of oxygen. The build up of CO2 caused by our breathing will rise to 8000 ppm and that is where faint headedness, dizziness, nausea sets in. If the environment is not rectified in time, by either 

1.  Releasing or scrubbing the CO2 away (by filters) 

2. Opening up the room and allowing the mixing of fresh air with O2 in and CO2 out

then the worse will happen ; disorientation, fainting and possibly death.

The Theory - General

Scientific studies have shown that elite athletes with well conditioned bodies (I highlight the words) can benefit from high altitude training. In the old days, many athletes went up to the mountains where the air was 'thin' and O2 levels were far lower than at sea level.

Live High (LH) 

This is where people who live high up the mountains, and endure low O2 levels for long stretches of time, for example, the Sherpas in the Himalayas. They have exceptionally well conditioned bodies. The reason ? Their haemoglobin levels in their blood are up to 50% more than ordinary people living at sea level height.

Train Low (TL) and Train High (TH)  

Training Low means to train at sea level.

Training High is to train at altitude of 3000 m and above

The Theory - Specific 

Our bodies have both aorta and veins, and smaller tubes called capillaries.In each cm3 of blood vessel tube, for example have (say) 10 haemoglobin molecules or small buckets whose sole function is to carry Oxygen molecules from the main O2 supplier (lungs) to the various parts of the body.

With the proper use of oxygen, the body breaks it down and burns in for produce energy for all manner of daily bodily movement from breathing, walking, running, everything.

So at sea level, say for 1 cm3 of blood there are 10 buckets of haemoglobin to carry 10 air molecules worth 10 oxygen content in size, so the effect is 100 HO of energy potential -  for example. (not scientific). So if a runner runs at sea level, at a certain speed which he is used to, he can use up to 100 HO of energy potential, and this is limited by the number of haemoglobin buckets in his per cm3 of blood.

In high level (3000 m - which is base camp Everest), the number of O2 molecules is far less say 10 molecules air but with 7 oxygen content per fixed volume of air. Then the person's energy capacity would be reduced to 10 x 7 or 70 HO. Thus, he would feel lethargic and not be able to run at the same speed.

Hence, your body's performance is limited by the O2 concentration in the air leading to anything from disorientation, altitude sickness, light headedness and slower work rate.  

To enhance his performance, the person would have to CONDITION his body by living in low O2 conditions for up to 2 weeks, so that :

1. The amount of haemoglobin grows in the blood vessels (it is amazing but true and backed by scientific research). It typically grows by 30 to 50% . So for 1 cm3 of blood, there can be up to 15 haemoglobin buckets in 1 cm3 of blood vessel - after conditioning in hypoxic rooms (rooms with low levels of Oxygen) for up to 2 weeks.

2. After 2 weeks, the athletes have (say) 15 buckets of haemoglobin and 15 molecules of air with 0.7 oxygen content, then the energy capacity is 15 x 0.7 or 105 HO. Over time and LH and TH, he can run at approximately the same speed but with less oxygen in the air.!

Magic ? No, the body is a tremendous adaptable machine !   

LHTLH or LHTL ? 

Science has shown that athletes with the program of Living High LH (3000) and Training Low TL (sea lavel) have the best results.

This means, that after 2 weeks of altitude training - either by living in the mountain at 3000 m height, and then going to train on the track in the sea level (0 metre), what happens ?

What happens ?

The height conditioned body  now has 15 haemoglobin buckets and at sea level (0 meters), there are 15 molecules with 10 oxygen content.

The persons energy capacity increases to 150 HO  or 15 x 10 HO ! 

He (in theory) can run by up to 50% faster than his original speed ! 

The effect is temporary as the haemoglobin level reverts back to 10 if the athlete stays at sea level - but the effect can last up till 2 weeks after return to sea level.

TL or TH ? 

Science has also shown that there are tangible benefits to train at both low and high levels of Oxygen. 

So here it is, the technology explained in layman terms 

Hence with the right team, technology, discipline and dedication, success for all our national athletes is a reality ! 

                                    The Completed Chamber Front View

Interested ? Gym Owners, Recreational, serious and elite athletes please contact :

QRA INTERNATIONAL PTE LTD.

Subject : 1.  Athletic Chamber 

                2. Walk - In Chamber for Humans

               3.  Gym Pod 

Email :    1. qrasales@qra.com.sg

                2. mark@qra.com.sg

Price Range : from S$  99, 000  (US$ 75, 000)  upwards

Laboratory for Biomed Testing Services.

 

                                                    QRA INTERNATIONAL PTE LTD.

QRA International is most pleased  to announce that we are at full capacity in Lab 1 at Toh Guan Road. We will be running full capacity till end of 2025, with a number of other tests proceeding till June 2026.

Many thanks to all our customers whose loyalty and support we are so appreciative of.

We have Lab 2 ready to provide top quality service and test reports according to 

ASTM F 1980 - 21 

Please feel free to contact us at 

https://www.qra.com.sg/our-services.

Or Email : mark@qra.com.sg

ASTM F 1980 - a summary

Here above is the summary of the ASTM F 1980 for Biomedical Products for Sterile Barrier Testing. The following assumptions have to be made below. 

1. Q10 is presumed to be 2. This is the aging factor.

2. It is not advisable to test the accelerated aging above 55 C, as the materials, mainly polyimide plastics and PET materials will melt.

In summary 

a) Typical (most common) temperature settings : 50 C   55 C or   60 C 

b) Typical Humidity Settings : 50 % 55 % or 60 %. 

For more clarity please contact :  mark@qra.com.sg or qrasales@qra.com.sg 

Website : www qra.com.sg 

Tel :  (65) 7895 1486  

 

ASTM F 1980 - 16 a summary

 

What exactly is the America Standard for Test and Measurement and why manufacturers need to test according to this and some other standard ? 

The America Standard for Test and Measurement is a standard for the manufacturers who wish to access US marketplace for their products. Products need to be tested according to stringent test conditions ranging from temperature, humidity, transport conditions, aircraft conditions and a whole host of other conditions to either 

- simulate

- stimulate 

the conditions in which the products are being subjected to, during their shelf life or the expected life of product.

The ASTM F 1980 - 16 focusses on Sterile Barrier mainly meant for the Biomedical or Biotech manufacturers. It states that the products must be subjected to ACCELERATED AGING and then sent back to the factory for assessment on product degradation and efficacy compromisation.

> In a nutshell

1. Products must be subjected to temperatures higher that what the operating shelf life of        the product is expected to be. So it is typical to assume that the products should be stored in temperatures normally (in most tropical and temperate) between 20 to 30 C.

2. There is a formula associated with the accelerated aging but I wont go into the fine details.  However, it follows the Arrhenius assumption that for every 10 C rise in temperature setting, the shelf life can shorten by half. There is an Accelerated Aging factor normally set at 2. The formula is a logarithmic function and to the power of the difference between the set temperature in the oven less the actual shelf life temperature divided by 10.

= Shelf life is 3 years 25 C for 36 months, setting in hot oven at 35 C is equal to 18 months,         45 C is 9 months and 55 C is 4.5 months 

= Shelf life is 5 years 25 C for 60 months, setting in hot oven at 35 C is equal to 30 months,         45 C is 15 months and 55 C is 7.5 months

Humidity setting is typically set in the region of 50 to 60%.

If you require more information, please drop me an email at 

mark@qra.com.sg

or go to 

www.qra.com.sg 

for more details.

We would love to hear from you. 

Digital Marketing with AI just changed the rules of the game.

This post is very important in this day and age. Let me share my own personal experience with my blog readers.Some years ago I attended the course called Business and Digital Transformation at the Singapore Management University. Over the course of roughly 1 year, I took in new concepts, bold and transformative ONLY if I firstly accepted 2 things :

a) The way I was managing my business was so last century and would only go downhill if I did not change my mindset about the shifting sands and paradigm shifts moving so fast in the global industry - let alone my small niche.  I had to firstly understand the industries in which my business was operating, which were its strengths and weaknesses, try to shore up the weakness and boost the strengths - all with the very limited budget - and go from there. Fortunately I managed to see through all the noise, and formulate the Vision 2030 which is what I have posted up on the top of this post.

b) After accepting that the problem was ME, I could then use all the tools at my disposal to craft a very cogent and clear message to the marketplace - in 2020. That was 5 years ago.

How so ? 

Well firstly the very fine instructors advised me to take advantage of all the social media platforms. Set up business accounts in as many of them as possible. Write stories of engagement, small successes, videos, services, products, new developments, new techniques and standards, customer reviews EVERY SINGLE DAY. 

The change was not easy, but slowly I set up accounts in all of the following social media platforms

a) Blogspot (this is my personal one which now also posts business related content)

b) Facebook 

c) Linked In

d) Youtube

e) Instagram

f) Google Ads

g) Website.

I engaged SEO specialists to push up key phrases and words. This was done over a year ago.

Then I employed an AI agent to craft me a marketing strategy to further boost up the company's presence and footprint. 

The results came slowly. Enquiries were few and far between.

Now it is moving and growing

Its a work in progress. There will be no end sight, just continual tweaking, boosting, and reviewing the data through the many data points in the platforms which have empowered the business owner to take full control of his marketing presence. It is no longer about how big you are in terms of revenue, profits, company size and resources. 

It is and will always be about CONTENT and what your company or organization will bring to the table to ADD VALUE to your customer's products and services. 

With this leg up, there is NO NEED to hire vast numbers of sales and marketing staff or account managers. It can all be handled by ME. The cost savings is tremendous.

Have a great day folks.