Here above is the summary of the ASTM F 1980 for Biomedical Products for Sterile Barrier Testing. The following assumptions have to be made below.
1. Q10 is presumed to be 2. This is the aging factor.
2. It is not advisable to test the accelerated aging above 55 C, as the materials, mainly polyimide plastics and PET materials will melt.
In summary
a) Typical (most common) temperature settings : 50 C 55 C or 60 C
b) Typical Humidity Settings : 50 % 55 % or 60 %.
For more clarity please contact : mark@qra.com.sg or qrasales@qra.com.sg
Website : www qra.com.sg
Tel : (65) 7895 1486
What exactly is the America Standard for Test and Measurement and why manufacturers need to test according to this and some other standard ?
The America Standard for Test and Measurement is a standard for the manufacturers who wish to access US marketplace for their products. Products need to be tested according to stringent test conditions ranging from temperature, humidity, transport conditions, aircraft conditions and a whole host of other conditions to either
- simulate
- stimulate
the conditions in which the products are being subjected to, during their shelf life or the expected life of product.
The ASTM F 1980 - 16 focusses on Sterile Barrier mainly meant for the Biomedical or Biotech manufacturers. It states that the products must be subjected to ACCELERATED AGING and then sent back to the factory for assessment on product degradation and efficacy compromisation.
> In a nutshell
1. Products must be subjected to temperatures higher that what the operating shelf life of the product is expected to be. So it is typical to assume that the products should be stored in temperatures normally (in most tropical and temperate) between 20 to 30 C.
2. There is a formula associated with the accelerated aging but I wont go into the fine details. However, it follows the Arrhenius assumption that for every 10 C rise in temperature setting, the shelf life can shorten by half. There is an Accelerated Aging factor normally set at 2. The formula is a logarithmic function and to the power of the difference between the set temperature in the oven less the actual shelf life temperature divided by 10.
= Shelf life is 3 years 25 C for 36 months, setting in hot oven at 35 C is equal to 18 months, 45 C is 9 months and 55 C is 4.5 months
= Shelf life is 5 years 25 C for 60 months, setting in hot oven at 35 C is equal to 30 months, 45 C is 15 months and 55 C is 7.5 months
Humidity setting is typically set in the region of 50 to 60%.
If you require more information, please drop me an email at
mark@qra.com.sg
or go to
www.qra.com.sg
for more details.
We would love to hear from you.
This post is very important in this day and age. Let me share my own personal experience with my blog readers.Some years ago I attended the course called Business and Digital Transformation at the Singapore Management University. Over the course of roughly 1 year, I took in new concepts, bold and transformative ONLY if I firstly accepted 2 things :
a) The way I was managing my business was so last century and would only go downhill if I did not change my mindset about the shifting sands and paradigm shifts moving so fast in the global industry - let alone my small niche. I had to firstly understand the industries in which my business was operating, which were its strengths and weaknesses, try to shore up the weakness and boost the strengths - all with the very limited budget - and go from there. Fortunately I managed to see through all the noise, and formulate the Vision 2030 which is what I have posted up on the top of this post.
b) After accepting that the problem was ME, I could then use all the tools at my disposal to craft a very cogent and clear message to the marketplace - in 2020. That was 5 years ago.
How so ?
Well firstly the very fine instructors advised me to take advantage of all the social media platforms. Set up business accounts in as many of them as possible. Write stories of engagement, small successes, videos, services, products, new developments, new techniques and standards, customer reviews EVERY SINGLE DAY.
The change was not easy, but slowly I set up accounts in all of the following social media platforms
a) Blogspot (this is my personal one which now also posts business related content)
b) Facebook
c) Linked In
d) Youtube
e) Instagram
f) Google Ads
g) Website.
I engaged SEO specialists to push up key phrases and words. This was done over a year ago.
Then I employed an AI agent to craft me a marketing strategy to further boost up the company's presence and footprint.
The results came slowly. Enquiries were few and far between.
Now it is moving and growing
Its a work in progress. There will be no end sight, just continual tweaking, boosting, and reviewing the data through the many data points in the platforms which have empowered the business owner to take full control of his marketing presence. It is no longer about how big you are in terms of revenue, profits, company size and resources.
It is and will always be about CONTENT and what your company or organization will bring to the table to ADD VALUE to your customer's products and services.
With this leg up, there is NO NEED to hire vast numbers of sales and marketing staff or account managers. It can all be handled by ME. The cost savings is tremendous.
Have a great day folks.
This post is a wakeup call for me and my cohort from the Baby Boomers (1965 to 1980), if we are still gainfully employed and still want to remain relevant in today's AI economy, I suggest attending courses from the 8 below. It is so critical to remain relevant and at least conversant of what is coming our way in the next 5 to 10 years.
1. Generative AI *
2. Data Analytics *
3. Cybersecurity
4.Data Science and AI
5.UI / UX Design
6. Digital marketing and SEO *
7. Blockchain and Cryptocurrency *
8. Advanced Data Analytics.
I truly want to attend at least 2 to perhaps 3 of these courses which are supported by our SkillsFuture grant from the Government of Singapore.
There is absolutely no time to waste.
This is the second of 2 parts, the first was in the previous blog post. My company QRA INTERNATIONAL has been around for 22 years and we started with the intent of supplying top quality equipment from a world renowned brand based in Europe to customers based in South East Asia.
This was when the concept of western brands were considered superior to the Asian brands (read Japan China and South Korea). However around 2011, we were unceremoniously disengaged from representing this brand and I took the crucial decision to do 3 things over the span of less than 10 years.
a) Look East
We sought and signed up agencies with Chinese and S Korean brands
b) Provide bureau services
We own 2 test laboratories that continue to do well. We focus and grow into new and more exciting industries for the next 20 - 30 years. I cannot specify which industries, but we are already 10 years ahead of the competitors.
The traditional businesses of general electronics, semiconductors, industrial combustion engine automotive manufacturing are all struggling. Some examples such as Delphi, Continental UTAC and Micron have downsized and moved out a substantive part of their business.
We also provide technical services to many MNCs on a regular basis, this is one of our mainstays why we continue to be around to serve our clients in as many as 10 different industries.
c) Focus on Long Term Industries of the Future.
Again as I stated above, the exciting industries are already here in Singapore and the region.It doesn't take a rocket scientist to find out what will be around for the next 20 - 30 years. Just look at the mega trends which will not change.
> People are living longer and healthier now for up to 3 decades than when the life expectancy was first used as a metric of quality of life for countries (it was around 70 in the 1970s for Singapore). Hence, the below 4 industries will continue their onward march and growth exponentially as researchers seek cures for life threatening cancer, diabetes, heart disease and stroke. The less dangerous but no less quality life reducing diseases of diabetes, back pain and gum disease leading to dementia are actively being researched and cures or treatments found every other week globally.
Singapore remains an attractive place due to its strong position of patents applications, ease of incorporation of new licenses, access to startup banking especially in the areas of compliance, sustainability and the circular economy. We as a country are AI ready, though setbacks occur ever so often.
While Singapore is expensive as a country to operate manufacturing of the established products like smartphones, LED TVs, etc etc,her strengths lie primarily in the following areas :
> strong IP marketplace
> sustainability practices
> research and innovation
> low corporate taxes
> AI and robotic innovation
> testing and validation
The old industries are facing major structural challenges globally and from the US using tariffs to arm twist and bully former trading partners. Its a very turbulent and non recoverable situation. The best way forward for us is to remain nimble, dominate the small niches we are already in and grow internationally through the smart use of social media and the apps.
Good Times with Great Mates Roland Teo ('V' sign) and Tom Gan If - Rudyard Kipling If you can keep your head when all about you...
