Athletic Chamber Installation in Aspetar Doha Qatar Hospital in 2017 - 5 Years before the World Cup !

 Hard at Work 

Installation in Doha Aspire hospital May 2017. 

QRA International has a flagship product which we will be making a global presentation in 2024. The athletic chamber is the 'secret weapon' for many Western sports associations for the longest time.

Many athletes have been using chamber technology to condition their bodies to get maximal performance for up to 2 weeks after use. This is testament to Singapore's fine performance of its track, sailing, and high jump athletes in the current Asian Games held in Hangzhou China.  

Now,with 2 chambers sold in Singapore (2015 and 2016) plus another 2 sold in Qatar (2017) and Australia (2018) respectively QRA is ready to 'let fly' the athletic chamber to the sporting world.

 

Levelling of the Floor at Aspire Doha 

Essentially the chamber is just a controlled environmental room. The limits of the controlled environment of the chamber is determined by the limits in which our world's environment. However, since there are no ultra marathons in -40 C in Kamchatka or Siberia, there is no need to control the temperature to -40 C. Most chambers which we design reach lows of 0C or -20 C. 

The highest temperature reached is +50 C which can be reached in desert climates like the Sahara and Gobi deserts. 

Temperature Range (Athletic Chamber) : 0  C to +50 C

Humidity levels are typically from 20% to 95% (Singapore's humidity is easily 70 - 80% most times of the year). The humidity in the chamber is controlled using steam generation (100%) and a cooling coil to reduce the RH by condensation. Rather overuse of power, but it generates the necessary humidity nonetheless. 

Therefore Relative Humidity : 20 - 95%

For elite athletes and conditioned athletes to train inside the chamber, QRA employs the use of Amine scrubbers which typically 'catch' the CO2 molecules from the air passing through and 'cleaning' the air to be pumped back into the room by this method. Human beings emit a lot of CO2 out into the atmosphere and a surprising fact if that many people die in enclosed spaces due to Carbon Dioxide poisoning rather than Oxygen deprivation or too low levels of oxygen when they are trapped in an enclosed space (say a closed mine, or skiiers in a crevice).

CO2 : less than 2000 parts per million per m3 of air.   

In summary, QRA INTERNATIONAL can provide the following : 

Walk- In Athletic Chamber for up to 10 people 

Size : 6 m x 6 m x 3 m 

Temperature Range : 0 to 50 C

Temperature Control : +/- 3 C 

Humidity Range          : 20 - 95%

Humidity Control         : +/- 5%

CO2 Control               : less than 2000 ppm per m3 of air inside chamber after 1 hour of intensive use.

Contact us Now for a detailed Discussion and No obligations Quote 

Email : qrasales@qra.com.sg

Website : www.qra.com.sg

Price Range : US$ 200,000 onwards 

Driving a Convertible in Europe - 1997 ( a Repost from Dec 5th 2008 2 - Living Life in the Fast Lane)

 

This photo was taken in June 1997, the year the first signs of the Asian Financial Crisis was starting to hit. The COE (Certificate of Entitlement) in Singapore that year was hovering around S$ 50,000 after having hit a record high of in excess of S$ 100,000 (!). I was in Germany for the agents' Worldwide Sales Conference for a week and my then business partner booked the Mercedes Benz SLK 420 convertible to rent for 3 days for a (then) reasonable sum of S$ 1,200 (about S$ 400 per day after converting from Deutchmarks). Petrol costs on the other hand, were another matter altogether ! Price per litre of petrol was hovering around DM 2 (S$ 2.00) per litre in France and DM 1.70 (S$ 1.70) for Germany.

To drive a luxury car in Europe is frankly one of us guys' pleasures and to drive a convertible at 240 km/hr on the Autobahn - there are no speed limits except for a few stretches near the big cities like Frankfurt, Cologne or Munich, is really something to be experienced. The Germans really DO appreciate and understand the mechanics and decades of technology advancement of the car (this is the country which produced the first petrol fired vehicle - Daimler) and the weather during spring / summer is perfect for this land tourer with the top down. Showy, YES but then LIFE is to be savoured within ones means isn't it ?

There is nothing quite like it over in this part of the world, firstly because of the humidity in S.E.Asia,and secondly there is NO WAY one can get by driving in Singapore or Malaysian highways at 240 km/hr without worrying when the 'Uncle Sam' (traffic police) is going to pounce on you.

Can I get 300,000 views by June 2024 ?

 

In Sevilla Dec 2022 

QRA International Test Services

 

20 Years of Providing Environmental Chamber Solutions  

QRA International's 21 years in the business has left a big imprint in many industries internationally. Our list of clients span from Defence Organizations, Sports Associations, Universities, Test Laboratories, Biomedical Manufacturers and Aerospace Parts Supplies.

Website : www.qra.com.sg

Email     : mark@qra.com.sg

  

                qrasales@qra.com.sg

                                               Make Better Great ! 

To achieve anything worthwhile with your life - be comfortable with being uncomfortable.

 

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.

Accelerated Aging ASTM F 1980 - 16 (21) and ISO 11067 QRA INTERNATIONAL only Lab focussed on Biomedical Testing Asia and Australasia

 

                                                                    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.

 

QRA Lab 1 at 21 Toh Guan Road East,

04 - 02 Toh Guan Centre

Singapore 608586

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.

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 (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?

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.

Please contact : qrasales@qra.com.sg

                           mark@qra.com.sg

                           www.qra.com.sg