Shelf Life and Accelerated Aging - Biomedical and Pharmaceutical Products

Every medical device is required by law to be labelled with an expiration date. The key question to every consumer is this. What exactly is an "expiration date" ? Is the performance of the device guaranteed  to be the same up until that magical date and then falls off dramatically after that ?

How do the manufacturers 'know; that the devices or products can really last that long ?

Thats where the decades long studies and the international standards have been put forth out in the market by top standards bodies such as ASTM (ASTM F 1980 - 21) and ISO (ISO 11607-1) for the US and European markets - the 2 largest consumer markets in the world for such products.

Testing your products and accelerating the aging of your products lends you credibility when you have the product rubber stamped on the box.

The test strategy for any biomedical or pharmaceutical company wanting to attain permission from  the FDA or the European market is to perform these aging tests by either : 

a) procuring accelerated aging chambers 

b) outsourcing these aging tests 

and conducting these tests.

For many biomedical devices that are manufactured from metals and robust plastics, the evaluation time for a product's shelf life  can be significantly shortened by aging the materials at elevated temperatures (as high as 70 C can be set).

Other products, such as biologic materials or products made of thermally sensitive materials, require a more thorough aging study design with environmental chambers relevant to more unique product requirements. 

Choose QRA International - the only Lab in Asia DEDICATED to 

ASTM F 1980 - 21   (for application for FDA approval to sell in USA market)

and ISO 11607 - 1   (for application to sell in the EU market) 

1. Establish product shelf life under both accelerated and real time conditions.QRA offers both test conditions at our 2 State of the Art Laboratories in Singapore and we are exploring setting up new Labs in Australia and USA. 

      An example : 

     Accelerated Aging in Chamber                              Real Life Test in Chamber

    55 C 50%    -  4.5 months         Equivalent to :          25 C 50% - 36 months (3 years)

2. Meet regulatory requirements following the ISO 11607 - 1 and ASTM F 1980 or any custom testing protocol needed to establish your products expiration date.

3. Start, Monthly, Weekly and End Test Reports backed by ISO 9001 : 15 traceability sent to you by email.

4. Additionally, QRA International provides comprehensive post tests, such as Peel and Bubble Tests to determine Sterile Barrier Hermiticity and package integrity

QRA also sells these shelf life testing chambers under our QRA brand. 

For more information, contact :

Tel :(65) 6795 1486

www.qra.com.sg

Email : 1. qrasales@qra.com.sg

            2. mark@qra.com.sg

There is never a better time to improve your products branding. Talk to the experts today. 

                            Laboratory 1 at Toh Guan Centre, 04 -2 Toh Guan Road East

                                                                   Singapore 608609 

  

Testing for Sterile Barrier Systems or SBS

Many Health Authorities worldwide recognise the critical nature of a Sterile Barrier System.

What exactly is a Sterile Barrier System (SBS) ?

         Tyvek Seal and Polyurethane Packaging form the Sterile Barrier System in this Picture 

This is the external barrier (some examples can be Tyvek material or Polyurethane seal) which separates the internal components, powders, medicines etc from the elements. Hence it is crucial that the sterile barrier is never compromised.

A key function of a sterile barrier system is to maintain the safety of a terminally sterilised medical device until its point of use - typically in a healthcare setting.

QRA International network of Laboratories can evaluate the sterile integrity of your final packaging design through a series of seal integrity  and seal strength testing outlined in ISO 11607 - Packaging for Terminally Sterilised Medical Devices. 

 Seal integrity testing identifies any leaks around the seal area of your packaging system.Seal integrity testing identifies any leaks around the seal area of your packaging system. Seal integrity testing is followed by seal strength testing to evaluate the mechanical strength of your packaging system and the force needed to separate and open the seal. A high numerical force value could indicate challenges in opening your packaging system by hand, and a low numerical force value could indicate poor bonding of materials.

Choose QRA International Medical Device Testing to help you to :

a) Validate your final packaging system 

b) Monitor proper device performance during the manufacturing process.

c) Establish material compatability and proper bonding to maintain the sterile environment throughout the shelf life of your product.

d) Ensure the seal of your packaging system does not change due to environmental stressors such as distribution and shelf life.

Tests Available by QRA and its partners :

Seal Integrity Tests

1. Visual Inspection (ASTM F1886)

2. Dye Penetration (ASTM F 1929  & F 3039)

3. Bubble Emission (ASTM F 2096)

Seal Strength Tests 

1. Peel / Seal Strength Test (ASTM F 88, EN 868 - 5 Annex D).

Interested ? Contact the friendly QRA International Sales Specialists at 

email : mark@qra.com.sg

            qrasales@qra.com.sg 

Or visit our website at www.qra.com.sg for more information 

Leaders Eat Last ; Traits a Leader must Have

  I have been in business for over 20 years. That is a pretty long time, and the time tested takeaways I have gleaned from the "School of Life" is this :

     Find a Purpose

a) The world owes you nothing. So never expect anything except fresh air and sunshine. The rest, you need to find out for your self what is your purpose in life.

     Focus 

Once you set your goals. Review them every day or at least every week. Be brutally honest about how far you are in reaching your goals and FOCUS on it every day. If you are not anywhere near it, you had better do something.

    Thick Skin

Develop a thick skin. There will be many brickbats and naysayers when you strive to achieve your goals. Do not be disheartened for you only receive the ultimate satisfaction once you achieve them not the people who dish out the criticisms.

Take a good look at criticisms and see if you really need to change course or adjust your goal expectation.

Even if everyone is against you, you know you need to press on. That is why you are the leader. Leaders make painful  correct decisions. Not populist ones.

     Humility 

Be humble in your achievements. This will always put you in the right path upwards.

    Courage

Be courageous (not foolhardy) to push through even though everyone is bailing out. It is a test of your derring do and try not to throw good money after bad. 

Stand firm.Take charge if your life. Don't be the one when at the your wake, people come up to your dependents and mutter :  

"Oh he was a nice guy but he just never went anywhere with his life"

Carpe Diem !!! 

To Be a Strong and Confident Person do these 7 Things ; Concept from Mr. Steve Wohlenhaus CEO at Weatherology

People  by nature do things to sabotage their paths to success. We choose to believe in the rhetoric of limitation, 

"No it can't be done."

"Its too difficult"

"You could have taken the easy route"

"You could've done better only if you listened to me !"

Sounds familiar ? 

Life isn't fair, and we should not depend on Governments of the day, family, or blame ill health, bad weather or genes to determine why you are stuck in the rut.

Everybody in power will say, "lets level the playing field."

Sure, but I think it will be a long time before the trickle down effect affects you, unless you are very high up the political heirarchy or are in some high end MNC.

We need to transcend the politics, and transform our lives NOW.

We do not make excuses and marinate in the mediocrity of blame and outrage.

No, No. No.

External events (global crisis, goepolitical events, natural disasters) are never the answer for personal improvement.

We must make personal improvement a goal irregardless of how well the economy is doing.

"Real transformation requires real honesty. If you want to move forward, get real with yourself"

"Do not kid yourself into mediocrity" 

In my next post I will identify the 7 traits and steps and I will act on them.

You should too.

  

  

Mental Toughness - The Works in a Single Slide ; Phase 1 - Identify the 4 Cs.

 

This is something which I want to improve this 2024 and beyond. My mental toughness. 'No more Mr. Nice Guy' is the tagline for the song, but its not quite an accurate description of my planned persona for 2024.

 

Step Up, Face the Heat, and Stay Focussed all the way till I get the goal attained

C (1) - Control 

Emotional and Life Control  

Always tell myself, when shit happens, I always have options to resolve and even improve the situation.  Never never go to pieces by becoming irrational or emotional ; whats the point in that ? 

Do a Risk Reward Analysis before venturing into unchartered pathways in life. 

Is it worth it ?

Confidence in my Abilities and Interpersonal Confidence

I am a very confident person, by nature, and every setback while painful, will shake my confidence - but to a certain degree - and no more. 

Pick myself up from the floor ; do a self check as to why the event occurred and what my price to pay is. Learn never to make that same mistake again 

Do not depend on external influences, friends, family, medicines or even religion to help you.

It is the power of positive thinking that will always claw you back time and again. 

Press On. 

Committment to the Goal (s) 

Once I am committed on a goal, I jolly well put 110% of my mind, abilities and resources to attaining this and completing it. No more no less. 

My very good friend Suresh who is based in Australia, gave me the Gantt Chart flow for me to assimilate into my life, the goals and achievements I have set for myself. I think this is an excellent piece of advice. 

Set the goals at the right, the timeframe I need to set aside, the resources I will need, the effort and the improvment in terms of infrastructure, staffing, opportunity costs and all. The more detailed I am, the better Control I will get and the easier the goal is attained with clarity.

I am assessing which of the 4 I am strong or weak with and will work on the weak ones.

Goal Oriented - strong

Achievement Oriented - strong

Learning Oriented  - strong

Risk Oriented  - quite weak

I saw this lovely piece some years ago and I'd like to repeat it to myself.

If you set 0 targets, 100% you will hit it all the time. 

Challenges

Is my glass half full or half empty ? Its so easy to lay in bed and wait for the sun toi reach midday and do nothing, it is a recipe for disaster. Depression, anxiety and all the ill health awaits people who just await the inevitable.

We all face setbacks every year, some more than others. If you always moan and groan and say "why me ?" what does that do in any way to make your state of mind any better ?

It doesn't. 

There are literally billions of people struggling and in worse shape than me and you. Think about it ! 

So, treat each event which made you unhappy or stressed as a challenge. 

Challenges are meant to be overcome, and not to be overwhelmed so much so that you lose focus of your life's big picture or calling. 

Once you overcome it, you learn from it and it will be an event you will smile when you recall that period.

One of the toughest mental stressing times  for me was during my National Service days in the artillary. That was in  the year 1981 and we 15 souls were selected to undergo 12 weeks of sheer hell on earth (my opinion). We were lance corporals and we went into the course to attain our 2nd stripe for full corporal status. 

I was and am proud to say I made it. We underwent the 120 mm towed mortar training which only the toughest minded (not physically strongest() ones survived.

I graduated 11th out of 15 Non Commissioned Officers with great pride and humility. 

The artillary training was crazy, stressful and we were constantly on our toes to be thinking out of the box, following terse instructions with severe consequences if we failed.

Many of my fellow trainees went to hospital for surgery, internal bleeding, and total blackout due to sheer exhaustion. I was struggling many times, but still persevered mainly through grit, and emotional support from my family. 

Those were trying times, but we made it.

Mental stress and ability to handle the stress is one determining factor of true success in life. Bite the bitter medicine. Press On. Complain less. Do the Tough Work when called upon. 

Make Painful Decisions. 

Today, many of my fellow ex-trainees are very successful in life and I am proud to be associated with them as a fellow graduate from one 

We will all die someday. Some from disease, some from unfortunate accidents, some from old age and some through mental health issues.

So what ?  Make the most of each and every year to the best of my (your) abilities. 

For in the end, what matters is that I (and you) try to leave a big imprint on the people around us and that is what truly matters. 

So I will go into 2024 with this GRIT mentality.

Time is no longer my friend. 

Success only comes to those who seek and try ever so hard again and again to attain it. 

2024 - Watershed Year for me in many ways.

 

5 Staff in our growing business

Happy New Year Everyone ! 

I will be referring to this blog every week to see whether I am on track of my goals.

2024 is the year of the last chances. My business while stable needs a major uplift in revenue to make it to the medium leagues. While we have good ongoing revenue from test services and repair, it is the major projects which I am confident will propel us into the big boys playing field. However, a lot of work and improvement of processes especially from me and the supporting people needs to be addressed and acted upon quickly. 

I am referring to the Athletic Chamber whereby QRA International is 1 of 4 international manufacturers or system integrators worldwide to provide such specialized equipment. I am confident we will secure 2 large orders in 2024. 

    2024 Business Resolutions 

1. Achieve Revenue of US$ 2,500,000 for the calendar year. 

2. Achieve US$ 500,000 EBITDA for the company (FY year basis)

2. Test Services business revenue to hit US$ 500,000 this year  (Calendar)

3. International distribution and repair services revenue to increase to US$ 300,000

4. Athletic and Human Performance Chamber Revenue to hit : US$ 1,800,000

    2024 Personal Resolutions 

1. Run 2 marathons (1 half  and 1 full)

2. Grow the Karate Club to 50 members

3. Help someone to finish his undergraduate studies -  remote and physical guidance

4. Reconnect with 10 worthwhile friends.

5. Volunteer in 1 social enterprise.

At the Doge's Palace Venice in Dec 2023 

The key issues for me Business Wise when  :  

a) Reach or exceed the targets set

> Stay Humble and do what is necessary

b) If the result is somewhere below the set targets stated below

> Decide what action to take.

c) Miss the target by a wide margin

>  What action to take

Time is of the Essence. Anybody can write nice platitudes and goals. The main difference is that the winners Make Tough Decisions, Grit and Plough On or Shift Course.

Let me leave you with these quotes in Latin and their translations below : 

> Carpe Diem ! 

   Seize the Day 

> Illijitimi non Carborendum !

   Dont let the Bastards Grind Me Down 

> Nemo Mortallium Omnibus Horis Sapit. 

   No mortal is wise all the time.

Every Setback has a Silver Lining - Many thanks to the efficiency of our Government Agencies

Recently I had my passport stolen in Italy. It was mainly due to complacency on my part. Even though we had a lovely time up until the incident, I let down my guard and hit the classic 'bump in the road' and it provided a rough and stressful last 2 - 3 days of our 14 day holiday which was unexepectedly extended to 15 days due to this incident. 

We are  seasoned travellers. We have visited most of Asia, Australia, and recently Europe for work and play for over 20 years in the past. This was the first time we encountered a major setback.  

However There is only so much vigilance you can exercise during your holidays. You do want to enjoy the scenery without looking over your shoulder or always tapping your tummy where your precious documents, money,credit cards are ever so often. 

With regards to your phone you, should hold it for dear life, else bring a cheap phone without all the important phone enabled tokens from your banks. 

Credit cards all over the world all operate using the Touch Pay method and it would be a major issue if one's credit cards were stolen. Yet it happens time and again.

My wife and I had our annual holidays in Italy and  recently we had a wonderful 12 days visiting Milan, Como, Pesqueira del Garda and Venice. At the 12th day on the train from Venice to Milan, we let our guard down and I had my backpack stolen in the Business Class section of the train.

Petty crime is rampant in many Italian cities. December is the most popular time to visit for Singaporeans and Malaysians (year end school holidays) so we (I) should have been much more vigilant and aware of the risks of putting precious documents, cash or cards in our backpack. There are teams of thieves identifying the potential victims which oftentimes are the hundreds of thousands of tourists which descend to St Mark's Square (Venice), Trevi Fountain (Rome) or the Eiffel Tower (Paris) and theft does happen.

Fortunately we kept our heads, and made the mandatory police report immediately upon arrival. We urgently called the Hon Consulate in Rome and was advised to do the following things immediately.

a) Go online to the ICA website and cancel my passport

b) File a Police Report at point of arrival (Milan in my case)

c) Take Passport Photo (for application of ID letter in Lieu of Passport)

d) Go to Rome with the PR and Photo for them to process speedily the ID Letter.  

Upon arrival in Milan, we made and received the Police Report as well as file the Online Lost Passport on ICA website.

We then made plans to make a mad dash to the consulate in Rome from Milan the following day (3 hours each way) to catch the staff at the Hon Consulate General to request for a Letter in Lieu of Passport signed and stamped by the Hon Consulate team.

The incident happened on a Tuesday (12th Dec), so on Wednesday it was mad rush to Rome, speak with the staff at the Hon Consulate.

When we arrived, they were expecting us. BUT the ICA did not respond to my notification of lost passport. They advised me to call the MInistry of Foreign Affairs in Singapore which has a 24 hours hotline for Singaporeans - and I did.

I spoke to an officer, and she was so helpful. She told me that as I was speaking to her on the phone, the email from the Consulate just arrived at her inbox. She acted quickly and instructed the consulate staff to proceed to the document, the Letter in Lieu of a Passport - for Singaporeans like myself who are in trouble or who need assistance.  

It was all done speedily in the space of 1 hour.

We arrived in Rome at 9.45 am, and reached the Consulate by 10.15 am. We managed to get the letter before 12 noon the same morning.

We then made plans to fly off on Thursday (14th) instead of Wednesday 13th ; an act which cost some money but the key thing was that my piece of mind was settled immediately.

Needless to say I was very grateful and impressed by the staff at the Ministry of Foreign Affairs in Singapore and the staff at the Hon Consulate General in Rome.

To Mr. Jacques Vicari, Ms. Patricia in Rome and the MFA in Singapore - my humble thanks and profound gratitude. We arrived back with minor delays (extra checks on Italian immigration and Singapore but only cursory as per the regulations). 

Acting swiftly and decisively, you have made me so proud to be a Singaporean.

Majulah Singapura !