If you want to be successful, you need to be uncomfortable. Everything which you are proud of in your life, you had to struggle and fight for it. Thats why it is so precious to you.
To achieve the great heights, you need to (be) :
a) disciplined
b) focussed (your goals)
c) mentally strong
d) persevere and pick up after each failure
e) hard working
f) lucky
I recall with much pride the 2 biggest single chamber sold in Singapore by QRA INTERNATIONAL in recent years to Defence Science Organization and Sports Singapore were very trying times, mentally and physically for me and my team. That was in 2015 and 2016.
In the end, when we completed it, and now when we look back, I am happy to say that we contributed in several ways to :
a) enhance the defence capabilities of Singapore through science.
b) enhance and improve the sporting excellence of our national athletes
To reach great heights in anything, business, sports, and in one's personal life a lot of sacrifice, blood, sweat and tears needs to be shed.
People only see the outcomes of that success. But they are blind to the sacrifices and toils which led to the final outcome. Many times, it is a sad ending.
Only the strongest mentally and physically survive the tests and an even smaller number climb up to the very top and achieve the unimaginable beyond their wildest dreams and plans.
Lab 1 at Toh Guan Road East
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.
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.
Purpose of ASTM F1980 (16 and 21 revisions)
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.
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 '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.
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.
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. 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. 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
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, Westpak recommends conferring with our sales team to determine the RH level to be specified in the test plan. Also, as per F1980-21, the rationale for uncontrolled humidity should be documented.
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?
Internal View of Athletic Chamber supplied by QRA INTERNATIONAL
Recently, our national sprinter Ms. Shanti Pereira has made the front pages of the news 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.In 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 : Sealevel 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 haemaglobin 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.
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, if for 1 cm3 of blood there are 10 buckets of haemoglobin to carry 10 air molecules worth 1 oxygen content in size, so the effect is 100 HO of energy potential - for example. (not scientific). So if he 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 1 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$ 100, 000 (US$ 75, 000) upwards
This is a 120 % super effective way to prioritise your time each and every day as well as weekly, monthly and so on. Spend a good 15 minut...
