QRA Vision Statement

 

A Constant Reminder to myself and my readers of the reason why QRA is in existence. 

Happy 27th Andrew !

 

Celebrating Andrew's Sweet 16th at Wooloomooloo Restaurant at Raffles City (2013)

2 days ago, my younger son Andrew celebrated his 27th birthday in Brisbane Australia. We wished him via social media and through Whatsapp. Here is a photo of his 16th taken some 11 years ago, time surely flies. 

Time has indeed been very kind to my family and I ; we have 2 grown lovely young men striking out in the working world, with all their future laid out for them.

May the good Lord bless Andrew and Noel with all the good health, happiness, family ties and some wealth in this world.

Do good and it will be repaid in multiples.

Carpe Diem.  

Last Push till end 2024 !

 

There is barely 2 months left of 2024. As I look back, I feel grateful that our Labs are at 90% capacity and my staff are well trained, motivated and hungry for more orders. The goals have been set very clearly and we push toward achieving the targets set. No ifs no buts no nothing. 

The word on the street is that a recession is imminent within the next 12 months as envisaged in the inversion of the long term bond yields as compared to the short term bond yields in Singapore's T Bills. No one seems to notice it ; or wants to make capital on it.

I will do the necessary ; get on with achieving what is needed on the business front, make investments to get that secondary income stream a reality and press on.

 

Inspirational Post

 

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.