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.