What’s AQL?
AQL is abbreviation of Acceptable Quality Level, is an international industry standard sampling process for evaluating the quality of a finished product. AQL measures quality by determining the highest number of defects accepted in a random selection of a product batch. AQL is widely used in the quality inspection of products in various industries, and different AQL standards are used in different products.
In AQL sampling, the same quantity is sampled, and the smaller the value followed by AQL, the less the number of defects allowed, indicating that the higher the quality requirements, the more strict the inspection is.
In disposable gloves’ field, the most common AQL level is 4.0, 1.5, 1.0 and 0.65. Gloves with an AQL of 4.0 are not suitable for medical use, they are for industrial and domestic use e.g. cleaning, garages, engineering, dirty factory jobs etc. For medical field, the suitable AQL is 1.5, 1.0 and 0.65. Although AQL 1.5 has been proven to be more suitable for general prehospital, emergency and first aid use, but 1.0 and 0.65 will give people more protection.
Traditionally, doctors donned gloves to protect the patient from the transmission of microorganisms. Today, with the growing numbers of HIV, Hepatitis B and C infections, surgical gloves play a more significant role in preventing the surgeon’s hands from the transmission of these blood-borne pathogens and viruses. Although surgeons expect their gloves to serve as an
effective barrier during use, but if the AQL number of surgical gloves is high, sometimes they may fail to protect the doctors. AQL tests measure and rate the barrier integrity of disposable gloves. Low AQL numbers indicate fewer pinhole defects, and higher levels of quality. To control the pinhole defects, and give the maximum protection for longer wear times, enterprise needs to invest more for good raw materials, better production environment & facility, excellent technicians and QC people. All these cost increases lead to a higher production cost
Take surgical gloves for example, Normally standard AQL is 1.5, means samples quantity 315 pairs, tolerance is 10 pairs. If AQL 0.65, for same quantity of sample, tolerance will be 5pairs only. Note that the numbers here are according to GB 7543. If it is EN455 or ASTM, the sample quantity unit is piece.
Higher AQL level of surgical gloves requires high level of producing environment, controlling production lines, dipping gloves smoothly, make sure no sand holes on gloves mould, no dust in workshop and devices; gloves are 100% air blow test to keep high AQL standards of 0.65; which means more cost and labor hands will be put into producing and discard many under qualified products; total cost is certainly increased much compared with common level products.
Why AQL is important?
Have you ever wondered why the new EN455-1 standard was published in 2020? EN455-1 is the standard for Medical Gloves for Single use, part 1: requirement and testing for freedom from holes.
New standard EN455-1:2-2020 was approved by CEN on 13, April.2020,
it supersedes EN45501:2020, which is withdrawn on May.31.2020
compared to the previous edition the main change is that the level for freedom from holes now is AQL of 0.65 for surgical gloves instead of AQL1.5.
Since COVID19 is spreading across the whole world in 2020, Surgical gloves play an even more significant role in preventing the surgeon’s hand from the transmission of the Coronaviruses.
However, there are no gloves manufacturers that can produce ZERO defect gloves, due to their nature thin of latex, highly flexible and the risks of puncture or rupture.
So with more stringent AQL 0.65, we could significantly enhance our personal protection and risks can be minimized and maximum safety maintained.
For rubber(latex) surgical gloves, one very important test item is Freedom from Holes (water leakage), the test result show as AQL, why this AQL level is very important for sterile surgical gloves?
The doctors wear surgical gloves to protect from cross-contamination, if AQL is high means more gloves have pinholes, the protect barrier is broken and the doctors are no longer protected from cross-contamination, which presents a greater risk of healthcare worker exposure to pathogens, so lower AQL better quality.
Who could make low AQL?
In different counties have different standards for AQL. There are just a few manufacturers in China can supply surgical gloves with AQL 0.65. HBM is one of the biggest. With the highest GMP standards in our gloves’ factory, we do random inspection 7 times before delivery, we test the gloves with water leak, air blowing (equipment from US). Besides, we not only inspect production batch randomly, but do QC 100% inspection, each glove is 100% tested. Under such advanced technology, super strict quality control and high sense of responsibility, we make sure all the surgical gloves manufactured to a very high standard at all time. We follow the latest European standard EN455-1- 2020, and always execute it ahead of other manufacturers. We believe AQL 0.65 will be the trend in the coming years, more and more end users will select the gloves manufactured to a more stringent AQL, then we could be offering our hands superior protection.
HBM manufacture medical gloves in quality of AQL0.65 which means quality level is much higher than the standard. HBM applied their new CE certificate with AQL0,65 gloves even before the new standard was published. AQL0.65 has always been their lowest internal quality control level,
They are using most advanced AI technology provided by Huawei to control dipping lines. Each batch of accumulation gloves from dipping lines is sampled and tested for pinoles using water tight testing.
Each glove will be 100% air inflation and visual inspected tested by US made air leak test machines. The machine will not accept any identified defects gloves.
Before packing process the gloves are inspected again for pinhole by using water tight test method based on ISO2859 sampling plan.
After the packing process, HBM QC will random sampling again to make sure final products can be released for shipment.
With all due respect, it is hard to get defective gloves if the manufacturers follow all above mentioned procedures.
However, due to surgical gloves being disposable and price sensitive products, most producers still follow the old standard and maintain AQL1.5 for surgical gloves.
In order to make to best gloves, Guilin HBM Health Protections Inc control the AQL strictly for each batch. Which strictly follow the rules to keep high level of AQL 0.65 to increase gloves quality and provide well protection for doctors, patients and users all over the world. Higher AQL also means less chance of gloves broken or have pin hole with time by to increase infection for doctors or patients.
In AQL sampling, given the same samples, the smaller the value followed AQL, the fewer the number of defects allowed, indicating that the higher the requirements on product quality.
We HBM promise that “Each glove is 100% air inflated and visually inspected” . While the glove can’t reach the standard, it will be discarded.The more that eliminate, the higher the cost. So the lower of the AQL, the higher of the price.
