Accelerated Aging and Sterile Barrier Testing Services by QRA International - Your Trusted Service Partner in S.E. Asia and beyond

                What Exactly is a Sterile Barrier and What Does It Do ? 

                   How does one test the Sealing of the Sterile Barrier ?

 

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

The sterile barrier is the external barrier (some examples can be Tyvek material or Polyurethane seal) which separates the internal components, powders, medicines etc from the elements. When we say barrier, it is normally a vacuum sealed package or polyurethane sealing which protects the internal to the external.

In most cases,it is either water resistant or water proof.

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)     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 :

Accelerated Aging Tests

1. Accelerated Aging Tests (ASTM F 1980 - 21 and ISO 11607)

2. Shelf Life Test 

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 

We are here to serve the International Biomedical Community 

Barcelona's Push Back against Tourists is a long time coming ; Decoupling of the World ?

 

                                                                    Waterfront Barcelona 

The recent push back by Bacelonan residents against the tourists is a disappointment, but not surprising. After a while, many locals I guess will be wondering "what is happening to my city ?" and will take action against the tourists, the majority of whom are law abiding and patronise the clubs, cafes and restaurants, in addition to the places of interest for example, 

1. La Pedrera

2. Joan Miro Institute

3. Parc Guell

4. La Sagrada Familia 

5. La Rambla

The reality of it all, is that tourism, warts and all, form a substantial amount to the gross revenue of the city. So, if there were no tourists, Barcelona would become something of a ghost town.

Easily 50% of its tapas restaurants, clubs and bars would shutter.

I guess, the compromise would be to limit the number of travellers to the city / country but that in itself is an impossibility, given the open borders to all neighbouring EU countries.

Is there a win win outcome to this situation ?

Spartan Mindset for Success

The Spartans were renowned for their fighting prowess against tremendous odds and they won many battles. When they lost battles, they lost them narrowly, always keeping to their iron discipline and dignity till the bitter end.

Spartans are a people who I really admire. When they are mightily outnumbered, they do not flinch because they have in them a particular mindset which encompasses these 6 rules. I apply my own life as an example.  

Uncomfortableness. 

Look back at your life. Remember the days and months or years you took to achieve something that was meaningful to you. It was pretty damn uncomfortable wasn't it ? My running and completing of 10 full marathons was exactly that. I would 

a) Get to bed by 10 or 10.30 pm latest

b) Wake up at 5 am sharp day in or day out

c) Do all my toiletries and head out the door by 5.30 am. Reach the start point and just 'Go'

   The only exceptions  were when it was raining cats and dogs or when I was overseas on a business trip/

d) Sweat buckets as I hit the tarmac and ploughed out 10 km to 14 km DAILY.

This tough regimen may appear crazy to many, but as a serious marathoner, it was LIfe.

I am very proud to this day that I did and completed the full 10 marathons, and many many half marathons.

Was it uncomfortable ? Of course, I got out of my comfort zone a long time ago.

Self Discipline 

With that kind of schedule, I had to turn down numerous social appointments and kept to an early start of each weekday. The weekends Sat was reserved for the even longer run of 14km to 20 km when preparing for an imminent marathon.

Growth Mindset 

Always keep a mindset to learn new things. With the digital transformation age well upon us, we must always keep learning and not be afraid to say I don't know and teach me. Then go and learn as best as I can.

Have a Sense of Purpose

I do have a 3 and 5 year plan in place. I also try to reach out to others to help wherever and whenever possible

Establish an Exercise Routine.

Im struggling with this at the moment, with life changes and timelines. I know these are excuses, but I set aside at least 3 days a week, 2 for runs and 1 for karate training to keep my body active and healthy. 

Eating healthily (avoid the processed bar foods as much as I can) and keeping the drinking sessions to a minimum, are also on my watch and control list. 

Develop Mental Resilience. 

Diamonds are produced under tremedous pressure over time and also heat impacted. The strongest metals like iron and steel are also heat derived. The strongest minds must be resilience BUT at the same time open to new ideas which will come up and challenge even the smartest of us all.

Take the Mental Resilience Route, But stay aware for new ideas and threats. 

 

QRA International Test Lab is at 100 % Capacity ; We are so grateful to our loyal customers

 

Focus, Resilience, Luck and Grit 

I have a dream, to make QRA International the 'go to' Test Laboratory for the S.E.Asian region for biomedical and pharmaceutical manufacturers and we will go on from strength to strength.

We will weather all storms, from cashflow, to fighting or market share, keeping our place in the heirarchy of Test Labs and build the brand into a global No. 1 brand for the space 

Test Laboratory for Biomedical manufacturers. 

7 Dec 2016 Placa Catalunya and La Rambla

At  Placa Catalunya 

The Centre of Barcelona like in any major city is the Main Bus and Train Station. Called the Placa de Catalunya, it is somewhere at the middle of the town, and at the start of La Rambla. To the north, that portion of the city is called Eixample. To the right, Barri Gotic,to the left, El Raval and Montjuic and to the south, the Waterfront.

Where we stayed is right smack at the waterfront and our hotel has  a lovely view of the Marina and the Mediterranean Sea.

 The Waterfront view from the Hotel along Passeig de Colom

The walk along Placa de Catalunya to La Rambla is a truly unforgettable one. The street is lined with pushcarts, there are lots and lots of pickpockets (I was one of the unfortunate ones who had his phone stolen literally right under my nose !). The pushcarts or pop up stalls sell everything from hamburgers, hotdogs, Barcelona FC T shirts (fake ones) and all manner of trinkets.

We stopped and went into the Jamon Museum where we saw how the pigs are reared happily for their meat and for how long are the meat cured before they are sold in the open market. 

The highlights of this first visit must be the La Sagrada Familia and Parc Guell which I will write another couple of posts on. We were getting pretty familiar with the place and I recall putting on my running shoes early one morning and running all the way along the Waterfront road Passeig  de Colom to past the World Trade Centre to some highway and return. Such was my passion those days that I brought my running shoes with me for our holidays and I tried to run everywhere we went. 

Statue of Christopher Colombus pointing to the Western shores. 

Mirador a Colom 

Christopher Columbus was in fact of Italian origin. He was commissioned by Queen Isabella to go West and discover new worlds, in the late 15th century and he is credited in 'discovering' the Americas. Actually, there were already the inhabitants in the Caribbean Islands whom he thought were Indians.

The design should be that he is pointing Westward. The travel guides like to joke that he is pointing to the Red Light District of Barcelona !!   

 

Street Artist along La Rambla 

I was setting goals since 2003 or 21 years ago. Here are 2012 goals

 

A Leather Bound Diary for a Stubborn Bricks and Mortar Man 

Good Goals - are so hard to achieve in one year 

I guess the burning question you who read my posts are these. Did I hit the goals of 2012 ? Well yes and no. I did hit hit most of those goals but nor as quickly as I wanted them (in 2012), but the key this exercise each and every year is this ; Set these goals. Set lofty goals. Keep them always in your mind.

Out of the 5 goals, so far, the Flying License and the 2 marathons per year are not fulfilled.

Am I ashamed I did not achieve them ? Well they are lofty and I am rather thick skinned. 

So only I am accountable to my lofty goals.

Set the goals, Yearly, 3 Yearly, 5 Yearly and break them down to quarterly, monthly, weekly and daily and DO THEM day in day out.

There is no other way.

Else I will have deemed myself as an abject failure with aimless motives in my life. 

5 Dec 2016 Day 2 Barcelona La Sagrada Familia

 

Picture taken from La Pedrera 

Designed and built with a team of top engineers, La Sagrada Familia is the stunning symbol of the city of Barcelona. Anthoni Gaudi was born in 1852 and studied in Barcelona's School of Architecture. His principal patron, industrialist Eusebi Guell commissioned to design the following iconic places and buildings 

a) Palau Guell

b) Parc Guell (we visited it and pix in later posts)

c) La Pedrera

d) La Sagrada Familia

In English the La Sagrada Familia is known as the Expiatory Temple of the Holy Family, which he embarked at the age of 31 or 1883. To date, it is still not finished, and there are vert few sharp or pointed edges of the Temple. The expected date of completion is 2026 

In 2010, the Nave was coveted and consecrated in an elaborate ceremony with Pope Benedict XVI as the chief guest. 

Inside the church you will be awestruck at the opulence and marvel at the engineering feat of creating the huge domes, which used counter weights and reinforced buttresses. A major engineering feat of the late 19th century then.

Inside the church you will see a huge statue of Jesus at the cross, and this is apparently the only one where he has his legs up and knees bent. The significance of this design is lost on me, but I recall with awe how the lowly shepherds and the poor working class in those days would take in the entire interior of the church with absolute gratitude and compliance. 

The fact that it took decades to finish and that the poor architect died a pauper's death (he was knocked down by a tram in 1926), when he was knocked down, no one knew this was THE Gaudi and he was not given any special treatment, as the story goes.