ASTM F1980 - 16 Accelerated Aging of Sterile Barrier Systems for Medical Devices ; Your Questions Answered Here

 

ASTM F1980 - 16 

Standard for Accelerated Aging of Sterile Barrier Systems for Medical Devices

ASTM F1980 is a test standard titled, "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices" is a testing procedure that is used to help with the assessment of the sterile integrity of a package and product designed for medical use.

In order to validate a product and package's Sterile Barrier System (SBS) over the intended storage shelf life, accelerated aging is conducted to evaluate a package and product's long term usability and efficacy. ASTM F1980 is a specific accelerated aging test protocol set forth by ASTM International (American Standards for Test and Measurement International)

It is also advisable to benchmark the product with Shelf Life Test which is to keep the product at the ambient temperature and humidity conditions for the entire duration of the product's useful life.

ASTM F1980-21 replaced F1980-16 in December 2021. What changed?

The revisions' primary change recommends that the use of controlled humidity during accelerated aging be considered, findings documented, and used during testing if warranted. The need for controlled humidity should be based on the characterization data of materials used in the medical device, it's packaging, and the long-term storage use condition.

Purpose of ASTM F1980 

To function safely and effectively, medical devices must maintain their sterile integrity throughout their shelf-life. However, over time, the physical properties of the materials may degrade in certain environments and, as a result, may negatively impact the safety and efficacy of the product. Because they endure so many unique environments while being transported, used, and stored, medical devices must undergo shelf life testing in addition to sterile integrity testing. ASTM F1980 specifically evaluates the aging process of a product along with its package and how it impacts sterility and shelf-life. Accelerated aging tests simulate these conditions by exposing the materials to elevated temperatures for shorter periods of time to represent an equivalent real time shelf life duration. ASTM F1980 testing offers valuable safety and performance insights to manufacturers. With a greater understanding of the aging process on a product and its package system as the result of testing, manufacturers can make more informed decisions regarding the handling, storing, and use of the product. Additionally, precise aging tests achieved by tight temperature tolerances offer enhanced assurance among regulatory agencies and consumers.

 

QRA Lab 1 at 21 Toh Guan Road East,

04 - 02 Toh Guan Centre

Singapore 608586

Frequently Asked Questions :

What is the procedure for an accelerated aging test for medical devices?

In accelerated aging tests for medical devices, a material or Sterile Barrier System (SBS) is exposed to elevated temperatures for a condensed amount of time. By exposing the testing materials to more extreme conditions during a shorter time frame, researchers can evaluate how a product will age under normal conditions without waiting for the entire desired duration. Armed with this knowledge, manufacturers can determine shelf life, storage, in-use, and transportation parameters more accurately for their product.

Accelerated aging is a standard practice in the medical device industry for determining shelf life parameters by accelerating the effects of time on a Sterile Barrier System (SBS).

The accelerated aging process is based on the relationship between temperature and reaction rate, in which the reaction rate increases as the temperature rises. The Arrhenius Equation is the basic formula used for an accelerated aging test for medical devices is:

Accelerated Aging Time (AAT)= Desired Real Time (RT) divided by the Accelerated Aging

Factor (AAF)

ln summary

Every 10 C increase in ageing temperature shortens the AAT by half.

Therefore if you have a product whose expected shelf life is 3 years or 36 months, the device is expected to 'age' or experience :

>  for ambient storage 25 C ; keeping the product in a chamber at 35 C, the product is expected to 'age' in 18 months.

>   for ambient storage 25 C ; keeping the product in a chamber at 45 C, the product is expected to 'age' in 9 months.

>   for ambient storage 25 C ; keeping the product in a chamber at 55 C, the product is expected to 'age' in 4.5 months.

NOTES

The calculated AAT is typically rounded up to the nearest whole day.

QRA does not recommend aging packaging materials at temperatures exceeding +65°C. Common Accelerated Aging temperatures (TAA) are +50°C, +55°C, and +60°C.

Ambient temperature (TRT) is typically between +20°C to +30°C. A temperature of +25°C is a more conservative approach.

The aging factor is typically between 1.8 - 2.5 with a value of 2.0 being the most common accepted value.

To perform ASTM F1980 accelerated aging tests for medical devices, the laboratory facility must identify the Q10 value of the testing sample. The Q10 temperature coefficient is a measure of how quickly a material system changes when the temperature is increased by

+10 C.

QRA Lab 2 at 7 Perahu Road

Singapore 718 836

What are some of the parameters for ASTM F1980 testing?

ASTM International sets forth specific test parameters to ensure consistent testing across different lab facilities. The basic parameters for ASTM F1980 include the following:

1.    Accelerated Aging Temperature

2.    Humidity (F1980 - 21)

3.   The quantity of product testing samples

After the Accelerated Aging Tests, it is advisable to send your medical products to

a)    Peel Test

b)    Bubble (full immersion) Test

to determine the Confidence and Reliability Levels. QRA can advise you on these matters.

Arrhenius Equation ; What is it ? Why is it Useful ?

Using the Arrhenius Equation, the TRT should accurately reflect the actual product storage and in-use conditions, generally between 20°C and 30°C.

Accelerated aging temperature should be identified prior to testing. This is done by having in-depth knowledge of your materials, product, and packaging. It is not recommended to exceed +65 °C.

The need for controlled humidity during accelerated aging should be identified prior to testing; if materials are subject to moisture degradation, 45% - 55% RH is suggested. This input should be determined with your material providers' assistance.

A Q10 factor needs to be determined, which involves testing materials at various temperatures and defining the differences in reaction rate for a 10° change in temperature. A typical Q10 factor used during testing is 2.

Accelerated aging factor should be specified using the following equation:

AAF = Q10 (TAA-TRT)/10

QRA's sales professionals can walk you through your product ageing test needs. 

What is the best temperature to use for an ASTM F1980 test?

The ASTM F1980 standard suggests using an accelerated aging temperature below 60°C. Aging your product at a greater temperature provides the advantage of a faster simulation of the aging interval, but this comes with risks for particular products and packaging materials. Medical devices are often engineered with delicate materials that may drastically change when exposed to temperatures exceeding +60°C. Finding out if your medical product or device may be adversely affected by long periods of high heat or low humidity is a good place to start when choosing the best accelerated aging temperature. Westpak's experts can help you define the ideal temperature parameters for your products and packaging.

Common Accelerated Aging Temperatures: 50 C, 55 C, 57 C or 60 C

Does the F1980-21 version require using controlled humidity during accelerated aging?

In short, humidity is not a required element of accelerated aging. The recent version suggests that humidity conditions in the aging study be defined before starting aging studies. If RH will not be controlled, the rationale for exclusion should be documented.

What is the best humidity level to use for accelerated aging?

Humidity usage is dependent on the materials used in your product and packaging, how moisture impacts them, and other environmental factors. If humidity during accelerated aging is to be controlled, Westpak recommends conferring with our sales team to determine the RH level to be specified in the test plan. Also, as per F1980-21, the rationale for uncontrolled humidity should be documented.

How do you evaluate the ASTM F1980 test, post-aging?

After a testing sample has undergone the accelerated aging process, its physical properties and package integrity will be compared against various aging time points.

This includes as per ASTM F1886, 

1. Peel Testing

2. Bubble Test 

3. Dye Test

My products must comply with the new F1980-21 revision. What do you recommend?

Whether you have a released medical device or a new product in development, QRA sales experts can help. Our recommendations will be based on your company's unique product, expected shelf life and how much you value your brand.

Please contact : qrasales@qra.com.sg

                           www.qra.com.sg

Presenting QRA International - Test Services for Biomedical and Pharmaceutical Industry

 

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.

4 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 submitted :

a) after end test (short and long duration)

b) before start of test

c) every month

3 QRA (Singapore) Chambers for Testing 

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

Parts are changed every 5 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 : evalyn@qra.com.sg

                qrasales@qra.com.sg

Lab Address 

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

Stability Test Chamber by QRA International

QRA Stability Test Chamber ; 

it has undergone the most severe Quality checks on reliability 

QRA brand is cheaper than the most inexpensive German brand by 60% !

QRA has unveiled (since 2023 beginning) the very latest Stability Test Chamber. We help many local manufacturers with their aging tests by ensuring their test products are tested according to the latest ICH (International Council for Harmonisation) for Pharmaceuticals and Human Use Guildelines.

QRA International test chambers are designed by us, made in Dongguan, China.

Chamber performance ranges are :

Temp : 0 to 80 C

Relative Humidity : 20 - 90%

Sizes 

175, 275, 400, 800 and 1000 litres 

Many local drug manufacturers have contacted QRA International with the intent to receive 

a) consultation

b) advice 

on the various standards before they can roll out their latest products to local, international (ISO 16007 for Europe, ASTM F1980 - 21 for US) standards.

Locally manufactured goods must at least have sent their finished pharmaceutical and health supplements to a certified test Laboratory or purchased a Stabililty Test Chamber  for purposes of conducting

a) accelerated aging tests  

b) real life shelf tests

Madincos Chart Recorder 8 Channels 

QRA Controller with colour touch screen LCD

with downloadable SD Card for data capture and plotting 

Price Range  

From USD 9, 900  onwards

Standard Offerings 

a) High Quality Chamber Galvanised Sheet Steel Exterior

b) Internal Stainless Steel interior

c) 2 stainless steel shelves

d) Inner glass door

e) USB stick with software for profile  download capture

f)  LCD touch panel with program setting

g) Mobile design (4 castor wheels)

g) IQ OQ PQ documentation for application to relevant authorities. 

For Further Enquiries 

a) email : evalyn@qra.com.sg

                mark@qra.com.sg

b) website : www.qra.com.sg

Why 37 C 80% rH feels far worse than 37 C 40%

"The heat of vaporization of water is the highest known. The heat of vaporization is defined as the amount of heat needed to turn 1 g of a liquid into a vapor, without a rise in the temperature of the liquid. This term is not in the list of definitions given by Weast (1964), so the definition comes from Webster's New World Dictionary of the American Language (1959). The units are cal/gram and values for the heat of vaporization of water at different temperatures are given in Table 3.1. The heat of vaporization is a latent heat. Latent comes from the Latin latere, which means to lie hidden or concealed. Latent heat is the additional heat required to change the state of a substance from solid to liquid at its melting point, or from liquid to gas at its boiling point, after the temperature of the substance has reached either of these points. Note that a latent heat is associated with no change in temperature, but a change of state. Because of the high heat of vaporization, evaporation of water has a pronounced cooling effect and condensation has a warming effect (Kramer, 1983, p. 8)."

The above is standard University Physics. We live in the equatorial or tropics where it is hot and wet most of the year. This year for the El Nino, we are experiencing searingly hot days interspersed with some rainfall. On the searingly hot days, we in the tropics seem to feel that we are under some heavy 'cloud'. That feeling is the humidity in the air. Our bodies are magnificent machines which have the ability to moderate and keep ourselves relatively hot or cold when the temperature changes - but up to a certain extent only.

So my post title is this, why does 37 C and 80% which is very humid feel so much worse than in the temperate countries where the humidity is much less ?

The answer is because, when it is hot, our bodies will sweat naturally, and since sweat is 90% water, it will stay on our body. The fact that water evaporates, because there is heat needed - which is from the body - to make it change to vapour without any drastic change of the external temperature. 

So, when that happens, a loss of heat or energy from our bodies translates to a cooling effect when water evaporates from our skin. This is presumed so, WHEN the air is dry. Hence, the feeling is that there is some cooling, even at 37 C.

However, when the air is damp or humid, like in the tropics, at 80% rH. Then when the water forms as sweat on the body, it is more difficult to evaporate or there is both evaporation (body loses heat) and condensation on skin (body gains heat) with a net heat exchange which is far less than when in a dry condition.

Thus, the feeling is that your body feels so much hotter as the sweat does not seem to evaporate or that the water is always there on your body - thus leaving the person feeling so much worse than at the same temperatures but much dryer.

The body does not lose as much heat and hence it feels much hotter than during dry conditions.

This can be seen at the marathons as there are NO timings which are world class times, even though the same world class runners come here to run at the same marathon distances and have just clocked far better times in the temperate countries.

 Temperature Vapor pressure Heat of vaporization,    ∆Hvap

   [°C]             [kPa[100*bar] [J/mol][kJ/kg] [Wh/kg]

0.01          0.61165 45054 2500.9 694.69 1075.2

2          0.70599 44970 2496.2 693.39 1073.2

4          0.81355 44883 2491.4 692.06 1071.1

10           1.2282 44627 2477.2 688.11 1065.0

14           1.5990 44456 2467.7 685.47 1060.9

18           2.0647 44287 2458.3 682.86 1056.9

20           2.3393 44200 2453.5 681.53 1054.8

25           3.1699 43988 2441.7 678.25 1049.7

30           4.2470 43774 2429.8 674.94 1044.6

34           5.3251 43602 2420.3 672.31 1040.5

40           7.3849 43345 2406.0 668.33 1034.4

44           9.1124 43172 2396.4 665.67 1030.3

50           12.352 42911 2381.9 661.64 1024.0

54           15.022 42738 2372.3 658.97 1019.9

60           19.946 42475 2357.7 654.92 1013.6

70           31.201 42030 2333.0 648.06 1003.0

80           47.414 41579 2308.0 641.11 992.26

90           70.182 41120 2282.5 634.03 981.30

96           87.771 40839 2266.9 629.69 974.59

100           101.42 40650 2256.4 626.78 970.08

110           143.38 40167 2229.6 619.33 958.56

120           198.67 39671 2202.1 611.69 946.73

140           361.54 38630 2144.3 595.64 921.88

160           618.23 37508 2082.0 578.33 895.10

180           1002.8 36286 2014.2 559.50 865.95

200           1554.9 34944 1939.7 538.81 833.92

220           2319.6 33462 1857.4 515.94 798.54

240           3346.9 31804 1765.4 490.39 758.99

260           4692.3 29934 1661.6 461.56 714.36

280           6416.6 27798 1543.0 428.61 663.37

300           8587.9 25304 1404.6 390.17 603.87

320            11284 22310 1238.4 344.00 532.42

340            14601 18507 1027.3 285.36 441.66

360            18666 12967 719.8 199.9 309.5

373.946            22064 0 0.0 0.0 0.0

 

a 5K Run in the Blistering Morning Vesak Day

 

The Frumpy Old Geezer Look 

I'm writing this in the comfort of my attic, after having completed a decent 5K run in the blistering hot morning over here in S'pore. While the weather at 9.20 am (yes I am a late riser), was already in the low 30s, I was determined to return to my old running schedule one way or the other.

You see, 2 weeks ago, I went and had an X-ray done at the S'pore General Hospital on both knees and while the assessment was mild OA onset, I am clearly mindful I can count the number of runs left me - maybe I have a decent 9 years before I have to accept the end of my running days.

Today's 5 K run (12.5 rounds of 400 m) was done and dusted at 39 minutes flat or on average a 7 minutes 46 seconds. Not fast times like last time but "Hey" who is counting the time ?? 

The orthopaedic doctors there thought I was a 'tough guy' to be able to consider running in my (very early) 60s but I am DETERMINED to succeed. My goal is to finish (maximum)  5 more marathons - hopefully all overseas and I will  finally call it a day.

No knee surgery, no wheelchair for this old fart, for the forseeable future, I am hoping.

  

I wish to grow old gracefully - if given the chance.

If there is one big wish I have, as I approach old age (to me that would be 80 years old).is that I would like to have for as long as possible, and in the due process, I wish that I can have the following 'abilities' which we take for granted when we are young (say from early childhood till 60).  

a) mobility, balance and endurance

b) have as clear a mind as possible (memory, cognitive function,direction,visual acuity) 

c) have all my hair   (LOL)

d) keep trim.  

e) can go to the toilet unaided

f) have a good night's sleep.

g) have a good appetite.

I see many people every day in the HDB estate nearby my office. Many are on mobile wheelchairs, some are bent and cannot stand straight and may be with or without their helpers or maids. The sight is getting very common in practically every Government and private housing estate.

We are a rapidly aging society. That is a fact. 

Singapore has one of the lowest total fertility rate or reproducing rate in the world, for every couple, our reproducing rate is 1.05 per every woman adult. Men cannot reproduce, hence only the women matter (of course I am joking !). 

While all the above 7 are deemed as normal processes of a working body, with each passing year, these 7 seem to be harder and harder to attain and maintain.

I pray that the longer I remain on this Earth, the wiser I get and the more patient I am of other people and less demanding on myself.

Price Elasticity and Inelasticity - what it all means.

 

The picture says it all. The total revenue for a product for example, is directly dependent on 2 factors.

a) Price per unit

b) Quantity Sold.

The sweet spot normally is where the Demand Curve (sloping downwards from Left to Right) and the Supply Curve (sloping Upwards from Left to Right) meets, and taking the 'Y' axis on the vertical would be the right Price and taking the 'X' axis on the horizontal would be the number of units sold AT THAT PRICE.

So, when would a product be deemed to be Price Elastic or Price Sensitive ?

PRICE ELASTICITY

It would be so, when for example, the item, lets call it a Kueh Lapis (multicolored desert) is first priced at $2.50 or at the top end of the green box. When the Kueh Lapis is sold at $2.50 and the demand is 35, then the total revenue would be as stated in the green zone or 35 x $2.5 equals to $87.5.

When the seller at the end of the day cant sell the remaining Kueh Lapis, and he reduces it to $2.0, there is a surge in orders or 55. Hence his revenue will then be $2.0 x 5.5 or $110.

The downside would be that he would need to make and sell more (55) for lower margin but the total revenue would be MORE than if he made less and sold them at a higher price.

Price Elasticity occurs when there are many other substitutes (many other snacks vying for my stomach when I need a pick me up, savory, sweet or just a bun), hence, people will buy more of this product when they deem it to be 'cheap' or inexpensive and can stretch their dollar to fill their stomachs.

Circumstances when price elasticity occurs :

a) many competitors and substitutes

b) small  price change and people are price sensitive. (daily necessities would be ideal catagories, such as toothpaste, toiletries, soaps, consumables, snacks,soft drinks and running shoes or sneakers are items which come to mind). 

This is PRICE ELASTICITY.

PRICE INELASTICITY

This would be when the product (say for example) petrol is priced first at $2.30 per litre, As there are very few other substitutes to petrol (once can downgrade the quality of his petrol, or else take public transport eschewing totally the need for his own transport but we are discussing the transportation function, say for a Grab Car Driver).

So hypothetically speaking at $2.30 per litre, the guy buys say 30 litres, and the total output he pays would then be $2.3 x 30 or $69.

If the price shoots up to $2.40, the poor guy still needs to fill up his tank, and so he skimps and tries to shorten his commute routes via Google Maps, he would still need close to 30 litres. So he is forced to buy 28 litres.

His overall outlay would then by $2.4 x 28 or $ 67.2

Price Inelasticity would occur when there is an oligopolisitic market (few players dominating the market such as petrol) and the item is deemed as a luxury item (branded handbags, designer shoes, petrol are 3 such products which come to mind). 

So which product technically is 'better' to sell ?  The one sold in price elastic market or the price inelastic one ?  The answer is "It Depends". 

Well, lets look at the cost or making these products.

a) For Kueh Lapis, say the cost of making one Kueh Lapis (time, ingredients, petrol to send to shop, rental, portion of business owner salary etc etc) is $1.00.

Then to sell 55 per day his margin would come to $55 daily. Working 6 days a week, that is 24 days per month, the gross margin from Kueh Lapis would be $1,320.

Of course, the seller would try to make as many different sweet desserts as he can in his stall, so this number above is totally meaningless. Unless  he can estimate the rest of his sweets and desserts he sells per day, can the owner then multiply the different margins he makes from the other desserts / sweets to see if his profit gained every month is worth his time, rent, and all the other fixed and variable expenses spent.

The same goes for the Petrol Station, as these are giant multi layered and multi country business entities which have been operating profitably for decades, making billions each year.

The bottom line is this :  If you want to go into business, choose one which has few competitors, and stick to price inelastic market places where you have a distinct advantage in your value add (whatever it is) and serve that small niche quietly.