I believe I have 3 more 42 kms left in my tank.

 

Salad Days - 2007 Marathon. 

ASTM F 1980 -16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices - QRA International Services

 

 

Medical Device Sterile Barrier Package Testing

Medical device packaging must maintain integrity over its claimed shelf-life under the storage conditions specified by the manufacturer. Real time aging programs provide the best data to ensure that packaging performance is maintained over the claimed shelf life, although due to time constraints in the product development process, QRA International also offers accelerated aging.

These 2 tests are run concurrently so as to provide accelerated aging results validated by real time benchmarks.

 

                             QRA has 16 Chambers available at short notice

Shelf Life Testing

QRA International performs testing on products at specific intervals over real time storage to provide accurate shelf life conclusions. However, the drive to get new products to the market often means that accelerated aging tests are often run in conjunction with real time aging to validate the product shelf life claims.

  

 

 

  

Accelerated Aging Testing (ASTM F 1980 and ISO 11607-1)

Our experts will tailor an accelerated aging test program to your particular requirements. We perform benchmark testing on products from the same batch before simulated aging to allow comparative post-aging testing at specified time intervals; a testing process which includes burst tests, dye penetration assessments, and peel strength testing.

 

 

Standards Complied by QRA International’s Labs

QRA International performs accelerated aging according to ASTM F1980 “Standard Guide for Accelerated Aging of Sterile Medical Device Packaging” and BS EN 868-8 “Packaging materials and systems for medical devices which are to be sterilized.”

Additionally, QRA International's labs also test according to ISO 11607 - 1 so we comply with all these international standards, so that your certification is made so much easier.

For more information :

Asia

E : mark@qra.com.sg

Europe

E : reypereira@qra.com.sg

USA

E :tim@qra.com.sg

Australia

E :clifford@qra.com.sg

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

Accelerated Aging and Shelf Life Testing - Video

 

Here are 2 videos explaining WHY acclerated aging and shelf life testing is SO IMPORTANT now, where customers demand product efficacy, peformance and functionality throughout the entire shelf life of the product, be it 3 years, 5 years of even 8 years.

In this age of recycling and circular economy, we are encouraged to REUSE, RECYCLE AND REFUSE throwing out stuff, hence manufacturers are mindful of :

a) Reusing unused products (off the shelf and not used up to date of expiry) ; the purpose of these accelerated aging studies and shelf life testing then falls on the designer of these products to 

> replace the material which has degraded during the shelf life, and implant into the product and ideally REUSE the unsold product at a cheaper price. This way there is no waste.

> RECYCLE also follows the same logic as reuse. 

The ultimate goal of the manufacturers is to offer products with the longest shelf life spans, so that there will be much less wastage year on year.

When that happens, losses due to waste is reduced tremendously adding to bottom line savings.

For more consultancy videos, watch this blog AND / OR email to :

Asia

E : mark@qra.com.sg

Europe

E :reypereira@qra.com.sg

US

E : tim@qra.com.sg

Australia

E :clifford@qra.com.sg

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

Intraocular Lens implants testing - send your products to QRA International.

 

Intraocular Lens of all types need to have sterile barrier testing. QRA International provides prompt, cost competitive testing with ISO approved test reports and upholding the highest standards of test protocols for International markets. We do the accelerated aging tests according to :

ASTM F 1980 - 16 (21)

ISO 11607 - 1 

for many opthalmic manufacturers worldwide. These tests are standard requirements for biomedical manufacturers of international standing and have been practised and approved by many standards bodies for compliance to international markets like the USA, Europe and Asia.

For more information and consultancy, please email to :

Asia

mark@qra.com.sg

Europe

reypereira@qra.com.sg

USA

tim@qra.com.sg

Australia

clifford@qra.com.sg

and a specialist will be happy to guide you through your test essentials and requirements.

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

Aiming for 500, 000 views by APRIL. Thank You !

 

I am in disbelief that my 'little' blog is now hitting 500, 000 in what I can only dream of, in a months' time. The last 2 months, I have had 100, 000 + views, I never in my wildest dreams imagined this could actually happen. I had targetted 500, 00 views by June, now, this is brought forward to April. 

Now, if only this will happen for my company QRA International  > the views >  then the enquiries > then the actual orders. 

Its one step followed by another. 

 

Excellent Pizza at Sam Leong Road. Pity about the ambience though.

 

Spicy Angel Hair Pasta with Prawns

Yesterday evening, my son and I ventured off Jalan Besar road, to a 'hole in the wall' eatery serving Italian food. Helmed by a Singaporean (I believe) named Fernando, this eatery makes one of the BEST Italian foods I have tasted this year. That is saying a lot, since I am a fan of Italian cuisine and have been to Italy 4 times in the last 6 years.

We ordered the following, as shown in the pictures above and below. 

1. Spicy Angel Hair Pasta with Prawns

This was my dish, and I enjoyed it very much. Only one comment, the gravy was overflowing which in my son's opinion, was too much. That was his opinion, though this dish suited me just fine. There was 5 - 6 fresh prawns in the bowl and I was overjoyed at my dish. 

Linguine Aglio Olio Pasta with Seafood

2. Linguine Aglio Olio with Seafood.

I would give this dish 10 out of 10. The linguine was just nice, "Al Dente' (chewiness) and the spicy aspect of this dish was a standout winner. There was ample seafood ingredients from fresh mussels, calamari and prawns interspersed with some spring onion. 

A winner.

Parma Ham with Burrata Cheese  

3. Parma Ham with Burrata Cheese

This is the Piece de la Resistance. The Magnus Opus of this eatery. The ham was thinly cut with just the right savory flavor and the burrata cheese was top class. The pizza crust was also not too thick neither too thin. So this, in my opinion is the top seller of this eatery.

Ambience - Not great ; barely acceptable

Its a hole in the wall. When we were there, the eatery was catering mainly to undergraduates and some people who didn't seem to be locals. In total, 10 people would be deemed full house. The area is not in the best part of town, that is all I would say.

The business owner Mr. Fernando is nice and welcoming. His staff are all friendly and helpful too. 

Pricing 

It is rather pricey. Just take a look below

> Parma Ham Burrata - $ 40 (for 2- max 3).

> Spicey Angel Hair Pasta with Prawns - $ 28 (1 pax only)

> Linguini Aglio Olio with Seafood - $ 28 ( 1 pax).

Compare this with Peperoni (Greenwood Ave and United Square)and their large pizzas (Speziale) is $28  for a 12 inch. The seafood aglio olio is also $27 for 1 pax, AND the portions are bigger (easily 50% more) than this place.

Ambience is much better (in residential area), and you get my drift. 

> For the food, would I go back there again ?  Yes definately.

> To dine in, how would I rate the experience ?  Barely acceptable.

> Price wise how would I rate it ?  Rather expensive, for the relatively small portion.

Fernando's Pizza

11 Sam Leong Road

#01-09  Trio Mall (newly opened)

SGP 207903

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.