ASTM F 1980 - 16 (21) a simple summary

 

What exactly is the ASTM F 1980 - 16 (21) ? 

It is simply the American Standards for Test and Measurement whereby biomedical products such as endoscopes, contact lenses (for example) must subject these products for 2 types of tests :

a) accelerated aging

b) shelf life testing.

What is Accelerated Aging

The standard (you can purchase it online) gives a detailed 5 page formula derived assertion that IF you wish to know how your products will age during its shelf life, the manufacturer must subject it to a test called accelerated aging. 

In essense, if the product's shelf life is 5 years (or 60 months), and it sits idle in the storage facility of the doctor's clinic, the standard asserts the following :

> Temperature (storage) : 25 C

> Humidity (storage)       : 50% 

The product must be subjected to a 10 C increase in temperature, for it to 'age' by 1/2 or the shelf life shortens by half. In this case, 30 months. So at 35 C, the shelf life is 30 months

If another 10 C increase is added to the storage temperature, then the shelf life shortens another 1/2 or 15 months. At 45 C, the shelf life is 15 months.

If another 10 C increase, the shelf life becomes 7.5 months. At 55 C, the shelf life is 7.5 months.

Now, ordinarily you would think Voila !, increase another 10 or 20 more C and you get 3.75 months and 1.875 months respectively.

Well, most biomedical products have Styvek polymer seals, and it will literally melt above 60 C, so practically it is not advisble to do accelerated aging for biomedical products above 60 C.

Most manufacturers would purchase a stability chamber which can do either of the most common accelerated aging tests.

Temp      : 55 C

Humidity : 50%

OR 

Temp     : 50 C

Humidity : 50%

Want to learn more ?

Speak to the experts at QRA International Pte Ltd.

Email :     mark@qra.com.sg    (Asia)

                reypereira@qra.com.sg (Europe)

We would be happy to discuss your test requirements and advise you in detail.

QRA International Laboratories - Focussing on improving Opthalmic and Biomedical Devices in line with ASTM F 1980 - 21

 

20 Test Chambers at 2 Test Labs in Singapore 

Presenting QRA International (Estd : 2003) . 2 Laboratories in 2 locations with 20 chambers for the purposes of :

a) accelerated aging

b) shelf life testing     (5 C, 30 60% rH)

c) photostability testing 

of products for biomedical, pharmaceutical industries in and around the region. We serve global opthalmic manufacturers, endoscope manufacturers, proximity sensors, and pharmaceutical product manufacturers looking for sterile barrier testing according to 2 internationally benchmarked standards :

a) ASTM F 1980 - 21 Sterile Barrier Testing for Biomedical Products

b) ISO 11607 - 1 

3 VC (Germany) Chambers for Testing 

Each chamber comes with its own Certificate of Calibration. (9 points)

Chart Recorder, Temperature and Humidity sensors are calibrated according to SINGLAS 

ISO 17025 - Laboratory Standard. 

Lab Test reports with Calibration submitted every :

a) end test (short and long duration)

b) start of test

c) month end

We also provide other types of test in house :

a) resistance testing

b) acoustic functionality

c) device functionality  

3 QRA (Singapore) Chambers for Testing 

Test chambers are routinely serviced (every 6 months) to ensure tip top functionality.

Parts are changed every 3 years due to wear and tear.

We keep chambers on rotation to ensure minimal downtime 

Customers are invited to visit our Lab - by appointment only.

3 ETSP (S Korea) Chambers for Testing  

Test with the Best, Test with QRA International 

Email to : mark@qra.com.sg (Asia)

                reypereira@qra.com.sg (Europe)

Locations :

Lab 1

21 Toh Guan Road East

#04 - 02 Toh Guan Centre

Singapore 608 609

Lab 2

7 Perahu Road

Singapore 718836 

Website : www.qra.com.sg

Aiming for 500, 000 views by June 2026! Amended Target.

Earlier last month, I set a target that the readership of this blog hopefully reached 500,000 by end of the year. That was roughly 150, 000 views for this year 2026 alone.

I am reviewing this number and setting it upwards. I believe in all sincerity, that the blog views will reach 400,000 by April and 500,000 by June 2026

I am just so grateful and thankful that people actually bother to read blogs these days, especially this small one which I started way back in 2008.

Thanks for the views.

We are all here on this Earth only for a short while, so do meaningful activities which assist our common man, and especially the people who mean a whole lot to us. By that I am referring to our immediate family,. our wives, our children, our in laws, our outlaws, friends, associates, and the people we come across in our lives on a daily, weekly, monthly or even occasionally. 

Be nice and kind. 

Be present. 

Be accountable

Be wise.

Be firm and fierce when I must 

Carpe Diem 

Courage isn't having the strength to go on. It is going on even when you don't have strength.

 

Nearing the finish line of my 9th full marathon in 2014. 

This is the words of Napolean Bonaparte to motivate myself when all around me are flailing and falling. 

"Courage isn't having the strength to go on. It is that you have to go on even when you don't have strength"

Take heart, there are countless people who have gone through the limits of pain both mentally and physically and overcome their greatest obstacles.

And when they do, they are so much more grateful that they went through the fire.

Wonderful Spanish Dinner at Kulto - Best Meal of 2026 !

 

Kulto (Sapnish Restaurant) 
87 Amoy Street

Description : Spanish Restaurant in a Shophouse setting. 

Jamon Iberico Croquette 

Yesterday, my family had a treat, courtesy of my lovely wife. We booked this fantastic Spanish place, called Kulto, which is located at 87 Amoy Street. Bookings are all done online, and to prevent 'no shows' there MUST be a surchage of $25 per person, IF there is a no show for the reservation.

I must say, this strategy, will really kill off any fence sitters who are booking just for fun and then at the last minute they change their plans. So, the dishes, as described by me. 

Jamon Iberico Croquette

===================

This tapas as a starter was exceptionally tasty, the crust was slightly crispy and the ham bits mixed with potato inside was a winner. Lovely to start the meal.

Grilled Octopus Galician Style 

Grilled Octopous Galician Style

========================

This one was a little mystery to me at first. We have been to Spain a few times, and when I first ate this tapas, I thought this was some form of back bacon. The octopus flavour of the sea was too camoflaged by the red chilli pepper and yellow eggy paste. Once I realised the chewyness, I then realised it was octopus done in an unusual way. OK, I liked it once I realised what I was really eating.

Iberico Chorizo with Crispy Potato, Organic Egg and Fried Kale 

Iberico Chorizo with Crispy Potato, Egg and Fried Kale

==========================================

This was my third favorite dish. The Chorizo sausage stood out for its  taste (something like our preserved Chinese Lap Cheong sausage) and the crispy potato, the onsen style egg and the fried kale made this dish a must try the next visit when I do get to visit.

Roasted Cauliflower Garlic Chilli Sauce, Mint Yoghurt and Hazelnuts 

Roasted Cauliflower with Garlic Chilli Sauce, Mint Yoghurt and Hazelnuts

=======================================================

The 'healthy option'. The cauliflower was nice, the hazelnuts stood out and the mint yoghurt gave this savoury dish some 'oomph'. Though it wasnt one of my top 3 favorites, I would say it is a necessary dish given there was little vegetables ordered. 

Seafood Paella 

(Seabass, Prawns, Clams and Mussels) 

Seafood Paella

============

The Piece de Resistance meal. The one that all of us gave a 11 over 10 rating. The seafood Paella which everybody raves about long after the meal is eaten, the reviews made and the memories locked in our basal ganglia. The seafood paella is so fresh, the 4 prawns were literally jumping out of the hot plate, the mussels, the clams all had no fishy smell. They must have been airflown in probably on the same day. 

The Paella rice was  savoury and light, it was  not sticking to the hot plate like in the other Spanish Restaurants. I must say this Paella rice is probably the best I have tasted in Singapore. (I have tried TInto,  Asador,  Pura Brasa and La Taperia). 

My Favourite Dish of last Evening. 

Aged Rib Eye with Mesclun Salad and Organic Peppers (500 g) 

Aged Rib Eye with Mesclun Salad and Organic Peppers

=============================================

One phase. 

"Out of this world" 

The marbling on this ribeye must have been M5 or M6, and while it literally melts in your mouth, the savory aspect of it, makes you want to come back for more. 

My second favourite dish of the evening. 

Kulto Cheesecake 

A fantastic end to a really superb meal ! The Kulto Cheesecake was not too densely packed, and the raspberry icecream, with the biscotti bits made this a grand finale to a truly unforgettable meal !  A must try. The head Maitre 'D gave this to us as an 'on the house' offering and really made our day ! 

My review of Kulto (I havent done one for close to 9 months).

Food         :  4.8 out of 5

Service     :  4.8 out of 5

Ambience :  4.0 out of 5 

Satisfaction: 5.0 out of 5. 

Overall     :   4.65 out of 5  (Fabulous !) 

Kulto (Sapnish Restaurant) 
87 Amoy Street

SGP 069906 

Accelerated Aging Biomedical and Pharmaceutical - 2026 QRA Laboratories in S E Asia

 

Why do Environmental Testing ? Watch this Video where I explain the rationale 

Test Laboratory (we have 2) in Singapore providing 

Accelerated Aging and 

Shelf Life Testing.

Common Test Conditions (Accelerated Aging)

===================

Temperature         : 55 or 60 C

Relative Humidity : 50 % to 55%  RH

Test Durations

===========

Duration :  5, 6, 9 or 11 months

Shelf Life Test Conditions 

====================

Temperature         : 30 C              (or 5 C) 

Relative Humidity : 60 % rH 

For more information contact :

Asia 

E : mark@qra.com.sg

Europe 

E : reypereira@qra.com.sg

Australia

E : clifford@qra.com.sg

HBOT Chambers from QRA International - The Latest in Wellness and Health.

QRA is proud to announce the launch of HBOT chambers  for :

> Wellness and Longevity

> Sports Recovery

in the Asia Pacific region.

Price from : $ 9000 onwards 

                               Soft Skin HBOT chamber for muscle recovery and wellness.

What does Hyperbaric Oxygen Therapy which is offered in Soft Skin Hyperbaric Chambers do  for you and me ? 

Theory 

There are 2 basic theories which are in the realm of physics :

a) Boyle's Law

b) Henry's Law. 

Essentially the application of these 2 laws 2 are these. For a fixed temperature, the higher the pressure, the lower the volume of the gas at constant temperature (Boyle's Law) and Henry's Law states that for a fixed volume, the higher the pressure applied, the more molecules of gas will be in the liquid at equilibrium. 

Henry's Law  

The amount of gas that will dissolve in a liquid is directly proportional to the partial pressure of that gas above the liquid. Breathing oxygen inside the pressure chamber increases the total amount of oxygen delivered to the cells by the bloodstream (Henry’s law). 

In addition, the increases in pressure result in a decrease in the size of bubbles (Boyle’s Law).An increase in ambient pressure (and thus partial pressure) results in more gas dissolving into the liquid portion of blood and tissues.

The definition of Henry’s Law (named after William Henry) explains that pressure is necessary for a gas (oxygen) to dissolve effectively in a liquid (blood plasma).

Gas will go from a higher density (lungs) to a lower density (tissues) to achieve equilibrium.

HBOT chamber for 6 people 

HBOT for 1 to 2 people. 

HBOT for 4 people 

Boyle's Law

If the temperature remains constant, the  volume of a gas is inversely proportional to the absolute pressure.

Studies have shown over the last 3 decades that for mild Hyperbaric Oxygen Treatment, which is providing the atmospheres and O2 levels as such :

a) 1.4 ATA or 1.4 bars 

b) O2 at 24 - 28% 

there are many health benefits to this treatment, if the person can stay in a Hyperbaric chamber for up to 1.5 hours at a stretch. The total amount of these 'treatments' to optimise the results and not cause harm is less than 50 times per year. In short, one 'treatment' per week.

Our body has 25 trillion cells, and with mHBOT treatment, nutrients and O2 can be input at a far higher rate than at normal atmospheric levels.

Increasing the atmospheric pressure while breathing in enriched O2 atmosphere creates an environment where O2 is dissolved more efficiently into the surrounding liquids, such as blood plasma and cerebospinal fluids.

During mHBOT we breathe O2 under higher than normal atmospheric pressures inside a soft hyperbaric chamber (much like a soft cocoon with windows).

There will be many amazing good effects on health or results from treatment using mHBOT. 

Therein is the magic of HBOT.  (Henry and Boyle Law in action). 

Contact :

Email : mark@qra.com.sg 

            reypereira@qra.com.sg

Website : https:\\ www.qra.com.sg