A Few Words On Courage

 

Mentally Strong People do these 18 Things - Last 6

1. Set Aside Alone Time 

This is so true. I prefer my own alone company at least 30% of the day, that is 8 hours.Take away 6 - 7 hours of sleep, I still have 1 - 2 hours during the workday thinking. Family and friends time do not interfere here. This is my way for many years, so I am used to this lifestyle.

Once, I do retire (within the next 3 - 5 years), I hope to keep the alone time sacred and spend time just focussing on my plans for whatever time I have left, and use that time meaningfully.  

2 Make Peace with the Past

I have failed on the following as I can recall. 

a) Not passing Chinese at 'A' levels 

b) Taking too easy a time earlier on in my career and rather choose to cruise and not push myself till I am about 50 years of age.

c)  Not building a larger company through a network of like minded business associates

d) Leaving project management to my staff when I should have been handson involved in at least 2 of the major projects since 2014. I have corrected my position, and nowadays lead from the front. This is the one true way to determine if my way is truly the most effective way to securing the deals.

3. Create your Own Definition of Success

I feel I have a good 5 - 10 years left in me for business.  What have my company achieved ?

a) Provided valuable testing for accelerated aging for biomedical and pharmaceutical manufacturers since 2017 and continue to be the sole Lab focussing on providing these important tests.  With 2 Laboratories grossing 4,000 ft2 in Singapore, we have clients from USA, Malaysia, Pakistan and Thailand who count on us. 

b) Sold, installed and commissioned the largest soldier performance chamber in Singapore by size and dollar value (US$ 890,000) in a single chamber thereby enabling our research scientists to develop better clothes, helmets, fullpacks for literally hundred of thousands of our NS men over these last 10 years.

We are still soldiering on and providing good service to the Military even today, 10 years since selling the equipment.

We MUST be successful then ?

c) Sold installed and commissioned the first and best Athletic Chamber in Asia in 2016 for elite Singapore sportsmen and sportswomen. 

Through the use of sports science, we are proud to say, we played a part in our athletes achieveing gold in both the 2016 Olympics and the 2023 Asian games.

d) Installed and commissioned a 2 athlete chamber for Qatar Hospital for rehabilitation of elite athletes in 2017. 

e) Installed and commissioned a 4 athlete chamber for an Australian University to provide research studies and papers for heat effects on elite athletes.

4. Spend Mental Energy Wisely 

This is so true. I know my mental energies and sharpness are best in the morning from 8 - 12 pm. So I make the key decisions during those times.

5. Stay True to Ones Values

This is the key to success.

a) Honesty to all in business and relationships

b) Put in 110% to all my endeavors

c) Be a fair person\

d) Meet with the winners

e) A dollar saved is a dollar earned.

f) Save enough so that my descendants can enjoy something when I am not around.

6. Retain Personal Power.

Personal Power I believe is charisma, the way you carry yourself and face all the obstacles in the world. Somedays you only want to curl up and stay in  bed. Well don't.

Life is short already as it is ; when you have personal power, you want to get things done and see that what your existence here on this earth amounts to.

True personal power I guess is changing people for the better. To achieve that, you first need to change yourself.

 

Taming the Falcon - - > Qatar Desert 2023

This experience is NOT for the faint hearted. The falcon is a top predator and can eat small mammals. One can rear falcons as a hobby but they are birds of prey so there is a lot of handling and training required before one can adequately own a falcon - or so I am told. 

So the trick is to feed them with scraps of goat or beef meat, then you can take the obligatory visitor photo, like I did.

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.