Testing of Sterile Barrier Systems for Biomedical Devices - 2024 Version Revised and Updated.

Many Health Authorities worldwide recognise the critical nature of a Sterile Barrier System.

What exactly is a Sterile Barrier System (SBS) ?

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

This is the external barrier (some examples can be Tyvek material or Polyurethane seal) which separates the internal components, powders, medicines etc from the elements. 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) Monitor 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 

Stuck Marmite Bottle Top - Why heat helps ?

Ever had problems with Bottle Tops are they are kept in the larder or fridge for a long time ?  I can hear a chorus of "yes !" from my army of readers (easily 1000 per day !). You huff and you puff, use some cloth and try with all your might. 

Eventually you get it open. Many times, it is stuck and you are mightily flustered. Ever wondered why ?

My experience in the field of environmental testing sales, manufacturing servicing of such test chambers for the last 25 years has the solution. 

Coefficients of thermal expansion. Yes, every thing heats up (or expands) when it is heated, however slowly. There are complex thermal expansion formulae, which is not necessary for this post. However each type of material heats up and expands according to the heat added to it.

You have heard how hot air rises ? Well air also expands as it is a gas but it is boxed in the receptacle (room, balloon or container) and it cant be seen. 

QRA has for years been selling thermal shock test chambers (see picture) whose purpose is to see if the samples do 'break' over time or over thousands of heat / cold cycles called temperature cycles.

   

   2 Zone Thermal Shock Chamber with Hot Zone (over 70 C) and Cold Zone (-60 C and below)

So, coming back to the Marmite bottle. You have tried for 1 minute. WAIT, you place it out in the kitchen (during summer time I am assuming). It was in the refrigerator for say 1 week. 

Come back after 15 minutes. It would have heated up to near room temperature (say 20C)

The 2 materials which are in contact with the Cap are Glass and the Cap (Plastic / Polyethalyne). See Picture Drawing Below Stage 'A'. 

Marmite builds Strong Bones and Teeth 

The Theory Explained in the Picture Below 

As the bottle heats up, the 2 materials will expand at almost microscopic amounts. Magnified under a scope, the cap will expand down and stretch out while the bottle expand up. (See Stage 'B').  If both had the same coefficient of thermal expansion, the points touching would NOT change.

BUT since plastic expands MORE than Glass, hence the movement DOWN is MORE THAN the movement UP by the glass.

Hence gaps will form.  You can then open the Bottle.

Voila ! Physics Explains this Everyday Frustrating Task and its Solution 

How to Heat Up the Bottle ?

Impatient people 

1.Put in a Microwave for 10 seconds or so (Not Recommended)

2.Immerse Fully Bottle in Hot Water

3.Use a Lit Match to Heat around the edge of the Bottle (we did that 40 to 50 years ago with  success). 

Everybody Else

Let it sit for 15 minutes and try again. 

HAVE A GREAT WEEKEND MY READERS ! 

 

Accelerated Aging and Shelf Life Testing according to ASTM F 1980 - 21 and ISO 11607 - QRA INT'L the only Lab specialising in Asia.

Every medical device is required to be labeled with an expiration date that is supported by shelf-life data. Accelerated-aging tests are employed to generate this data for design-history files, technical dossiers, and 510 (k) submissions, while concurrently running real-time studies.

For many medical devices that are manufactured from metals and robust plastics, the evaluation time for a product’s shelf life can be significantly shortened by aging the materials at elevated temperatures (often as high as 55^oC). Other products, such as biologic materials or products made of thermally sensitive materials, require a more thorough aging study design with environmental chambers relevant to more unique product requirements.

QRA Walk In Chamber 

With more than  3000 ft2  of environmental chamber space in 2 Labs, meeting ASTM, ISO, and ICH conditions, QRA International's network of laboratories has the capacity for accelerated aging and real-time shelf-life studies to meet your needs quickly, inexpensively and  with full test report submissions.

Our chambers are housed in secured areas, continuously monitored and integrated iand regularly calibrated in accordance to ISO 17025 International Safety Standards.

Website : www.qra.com.sg

Email     : mark@qra.com.sg 

                qrasales@qra.com.sg

QRA INTERNATIONAL PTE LTD. 

(TEST LAB FOR BIOMEDICAL AND PHARMACEUTICAL INDUSTRY)

Address  : 21 Toh Guan Road

                 # 04 - 02 Toh Guan Centre

                 Singapore 608609

Tel  : (65) 6795 1486 

Choose QRA INTERNATIONAL PTE LTD.  to help you : 

• 1.Establish product shelf life under both accelerated and real-time conditions. 
• 2.Meet regulatory requirements following ISO 11607-1, ASTM F1980, or any custom-  testing protocol needed to establish your product’s expiration date.
• 3.Get comprehensive analysis through one provider, including package integrity, sterility, and product functionality testing such as mechanical, electrical, and physicochemical testing.
• 4.Access study progress through our regular test report updates..
• 5.Ensure easy monitoring of multiple long-term studies and a device’s overall protocol plan using a document control system.
• 
  
• 6.Utilize an International Shipping Specialist (DHL) to  ship products anywhere in the world, navigating permitting, importing and customs.
• 
  
• We have test customers from USA, Middle East, Australia and Asia 
• 
  
• 7. Support protocol writing and method development / validation.

Lets make this life a good one. Can I get 300,000 views by June ?

Recently, I had a revelation. But I have come to realise that to be remembered, I need to provide some value to the people around me. In addition, after a certain time,  you see many things with the clarity of accumulated experience and shared experiences of your family, friends, business associates and aquaintences.

I learn what I don't want to end up as

I understand my limitations

I understand my strengths

I realise that you can't please everybody so its better to prioritise who you must please first and foremost.

I realise that I am a leader and leaders need to serve first and foremost. 

I need to give my team the right direction and then if they go astray I need to bring them back to the correct path.

Priorities in Life ( Most important ranked 1) 

1.Health

2.Your Relationships with your Partner Spouse

3.Family Cohesion and Care (Filial Peity)

4.Money

5. Friends Situations. 

6. Business and Appearence

I believe I do not need to elaborate on each one as these should be self explainatory 

Some Mismatched Priorities

Different folk will place the items in different order, hence I will not explain the rationale for mine. 

QRA's Lab running continuosly for Accelerated Aging Tests

QRA INTERNATIONAL PTE LTD 

HQ : Singapore

Subsidiaries (2024) : Australia

(2024) Thailand.

We have 20 Test Chambers in 2 Labs ready to serve our clients worldwide 

Email : mark@qra.com.sg

Website : www.qra.com.sg

Tel : (65) 6795 1486 

Accelerated Aging and Shelf Life Testing - according to ISO 11607

 

What is the meaning of 'shelf life' ?

Shelf-life testing demonstrates the ability of a packaging system to maintain sterile integrity and strength over a defined period of time, and is indicated by labelling the product with a use by or expiry date.

Shelf life is defined as the length of time that a product may be stored without becoming:

• Unfit for use
• Unfit for consumption
• Unfit for sale

QRA operates 2 Labs with 20 test chambers running 24 hours 7 days a week 

What is accelerated aging?

Accelerated aging is an artificial procedure used for establishing the shelf life to estimate the useful lifespan of a product when actual lifespan data is unavailable in an expedited manner.

Accelerated aging is conducted by simulated exposure of the product to elevated temperatures and realistic relative humidity levels for the equivalent period claimed for product expiration. The provisional accelerated aging expiration date will remain until real time aging results are acquired.

Typical Accelerated Aging Temp and Humidity Conditions 

1. 55 C 50% RH

2. 60 C 50 % RH 

Typical Duration of Tests 

1. 18 months

2. 9 months

3. 4.5 months

What is Real Time aging?

Real time aging is a stability testing process used to provide real data to determine the shelf life and the effects of aging on materials over time. The packaged product is exposed to storage conditions such as temperature and relative humidity to determine its shelf life. These studies are typically carried out at ambient temperature between 25°C to 30°C.

Humidity is also controlled with settings of between 40 to 60% being the most common settings. 

How is accelerated aging calculated according to ASTM F1980 ?

Accelerated aging techniques are defined on the basis that the chemical reactions involved in the deterioration of materials follow the Arrhenius reaction rate. This states that a 10°C temperature increase results in approximately two times an increase in the rate of the aging process. The accelerated aging process is based on the relationship of temperature and reaction rate where an increase in temperature increases the reaction rate.

The level of relative humidity (RH), should be included at realistic levels. When controlling humidity during an accelerated aging study, it is suggested in the standard to use a realistic level between 45% RH and 55% RH unless there are documented reasons for using other humidity levels. If other levels are used, a rationale should be documented.

• It is not recommended by the standard to age packaged products at temperatures above 60°C unless knowledge of the materials shows otherwise
• The calculated duration is normally rounded up to the nearest whole day
• Ambient temperature Real Time Temperature (TRT) is typically between  25°C to  30°C
• The aging factor of 2.0 is the most common value but other levels between 1.8 – 2.5 may be used once sufficient knowledge of the materials are known and can be justified

Product temperature storage labelling considerations

Where a product is labeled with specific storage temperature range, the upper temperature listed should be used when calculating the accelerated aging duration. This is instead of the normal ambient temperature (TRT), which is typically 25°C or 30°C. If the labelled range is 15°C to 35°C, then the 35°C should be used as the ambient temperature TRT in the calculation.

Timepoints:

It is recommended that minimum of two shelf-life timepoints are used. This provides a backup if post aging tests do not meet acceptance criteria for a particular timepoint.

QRA offers a range of accelerated aging chambers, which can accommodate both large pallets and single shipping units.

Stability Testing

What are stability studies?

Stability studies are conducted to evaluate the quality of a pharmaceutical or drug product over time to evaluate the influence of various environmental factors such as temperature, humidity, and light. Typically, under accelerated conditions, this simulates the effects of long-term storage in a shorter period of time.

STERIS also offers stability testing capabilities in accordance with ICH guidelines for pharmaceutical manufacturers.

Conditions include:

• 5°C
• 30°C, 60% RH
• 30°C, 65% RH
• 30°C, 75% RH
• 40°C, 75% RH

Interested ? Talk to the Experts  Contact

QRA International Pte Ltd. 

Website : www.qra.com.sg

Email    : mark@qra.com.sg

Tel        : (65) 6795 1486 

To be the 'Go To' Person or Place - Just Follow Qatar

 

At the Souq Waqif in Doha 2022

Just look at Doha now. Prior to 2022 FIFA World Cup, very few people had heard of the place let alone visited it.

They are now on everyone's lips in terms of world sports events. 

This did not come by chance.

This was all planned for the last 20 years ; Meticulously and engaging top people with lots of experience in events management of the grandest scale.

For an individual, it is simpler. In the following days and weeks I will show you how to boost your followers and popularity on several social media platforms.