Allergic reactions complaints for a protective apparel (impervious gown)

[beluga123]

Several months ago, we received a few allergic reaction complaints for a protective apparel (impervious gown) made with PE laminated SPP (Polypropylene) fabric. This is the only material used in this gown. No thread, latex elastic...etc. is used on this gown. The customers complainted about redness, itchness...etc. allergic reactions on the face. The gown is worn on the body only. There was no contact with the face under normal user condition. We sent complaint samples to an US lab for the Cytotoxicity and Skin Irritation Tests. Both Test passed. A few days ago, our factory reported that 6 workers (out of 60) complained about the similar allergic reactions when they were making the same gown. The fabric supplier said that they did not make any change in the materials or manufacturing method. Our factory checked possible environmental factors and could not find an assignable cause. The production resumed with another lot of the same fabric yesterday, but there was no worker complaint so far. I would appreciate if anyone can share their experiences on any allergic reaction to this type of material. Any suggestion for investigating this issue is greatly appreciated. Thanks!

[GStough]

Originally Posted by beluga123

Several months ago, we received a few allergic reaction complaints for a protective apparel (impervious gown) made with PE laminated SPP (Polypropylene) fabric. This is the only material used in this gown. No thread, latex elastic...etc. is used on this gown. The customers complainted about redness, itchness...etc. allergic reactions on the face. The gown is worn on the body only. There was no contact with the face under normal user condition. We sent complaint samples to an US lab for the Cytotoxicity and Skin Irritation Tests. Both Test passed. A few days ago, our factory reported that 6 workers (out of 60) complained about the similar allergic reactions when they were making the same gown. The fabric supplier said that they did not make any change in the materials or manufacturing method. Our factory checked possible environmental factors and could not find an assignable cause. The production resumed with another lot of the same fabric yesterday, but there was no worker complaint so far. I would appreciate if anyone can share their experiences on any allergic reaction to this type of material. Any suggestion for investigating this issue is greatly appreciated. Thanks!

Hi beluga123,

My former employer had a similar situation a number of years ago with certain types of fabrics from one supplier. After a series of tests, it was determined that this fabric had been exposed to higher than usual levels of formaldehyde during one of the supplier's processes. This exposure to an increased level of formaldehyde resulted in several employees complaining of skin and eye irritations; skin from coming in contact with the fabric for extended periods of time, and eye irritation from the strong fumes present in the fabric.

After some back and forth communication and corrective action with the supplier, the issue was finally resolved. Regular monitoring of the air quality was a direct result of this experience, which was a good thing.

However, it doesn't sound as if this is the same kind of situation in your company. I'm not sure what else it might be, but perhaps the supplier of the fabric may be able to visit your facility and determine what the problem is and the options for resolution.

I hope this helps. Good luck to you...

[MIREGMGR]

Originally Posted by beluga123

Several months ago, we received a few allergic reaction complaints for a protective apparel (impervious gown) made with PE laminated SPP (Polypropylene) fabric. This is the only material used in this gown. No thread, latex elastic...etc. is used on this gown. The customers complainted about redness, itchness...etc. allergic reactions on the face. The gown is worn on the body only. There was no contact with the face under normal user condition. We sent complaint samples to an US lab for the Cytotoxicity and Skin Irritation Tests. Both Test passed. A few days ago, our factory reported that 6 workers (out of 60) complained about the similar allergic reactions when they were making the same gown. The fabric supplier said that they did not make any change in the materials or manufacturing method. Our factory checked possible environmental factors and could not find an assignable cause. The production resumed with another lot of the same fabric yesterday, but there was no worker complaint so far. I would appreciate if anyone can share their experiences on any allergic reaction to this type of material. Any suggestion for investigating this issue is greatly appreciated. Thanks!

Three thoughts:

1. "...PE laminated SPP (Polypropylene) fabric. This is the only material used in this gown. No thread, latex elastic...etc. is used on this gown."

With all due respect, that sounds like "the spec sheet says it's pure, so it must be pure." Have you had a chemical analysis done to determine whether something else is present in micro quantities? Keep in mind that a sensitization effect could be due to something present in the parts-per-million range.

If the PE is laminated to the PP via a flame technique, it's guaranteed that complex organics are present. If the fuel-gas for the flame-lam line was unusually heavily loaded that day with odorant, there will be sulfur and nitrogen present in the complex organics as well as C, H and O.

2. "We sent complaint samples to an US lab for the Cytotoxicity and Skin Irritation Tests. Both Test passed."

It's conceivable that the guinea pig model used in ISO 10993-10 isn't effective for your sensitizer, if what's occurring amounts to an allergic or immune reaction.

This comment was made some time ago about 10993-10 by experts from NAMSA, an experienced lab:

"The guinea pig sensitization tests described above are useful methods for eliminating the possibility that patients will be exposed to strong sensitizing chemicals extracted from medical device materials. However, these methods are far from perfect in their ability to detect weak sensitizers or chemicals, or those present in low concentrations, and they do not detect chemicals that act as adjuvants, enhancing an immune response to other chemicals to which a patient might be exposed. Nor are they able to detect responses to antigens such as plant proteins (...) "

"Additional test methods currently under development may prove useful for evaluating biomaterials for sensitization. One test that shows promise is the local lymph node assay in mice. In this method, the ears of mice are treated and then the surrounding lymph nodes are examined for a lymphocyte proliferative response as demonstrated by an accumulation of a radio-labeled marker."

3. One interestingly useful, quick and free contamination test on polyethylene-film-laminated material is for someone with a sensitive sense of smell, and some experience using it in a materials-engineering sense, to sniff a swatch that's just been unrolled. Pure polyethylene should have zero smell at room temperature...but industrial-sourced material (or even food grade) is almost never that pure. Tiny percentages of contamination in polyethylene can be detected by smell.

Sense of smell is gender-dependent, though the oft-mentioned 10x greater average sensitivity of females over males is unreliable because it's an average and because sensitivity differences actually depend on the chemical being smell-detected. It's pretty effective, though, to just ask people who has a sensitive sense of smell. Most of the volunteers will be women, and their self-evaluation will be pretty reliable in my experience. In a production context, this can be used as a material QC tool by just having a designated individual sniff each roll of material after a couple of layers have been unrolled to detect if it's "different" and needs to be investigated by a materials engineer.

[beluga123]

Dear Ms. Stough,

Thank you very much for your input!

We will definitely look into the formaldehye issue. We will also look into the possibility of obtaining a formaldehyde detector to monitor the air quality in our production room.

Again, I greatly appreciate for your valuable inputs.

Best regards,

Beluga123

[beluga123]

Dear Miregmgr,

Thank you very much for your inputs.

We ran the FTIR and DSC Analysis on these fabrics previously, but did not find anything unusual. We also used Scanning Electron Microscope to check the fabric structures, but it also did not show anything abnormal.

Any suggestion for performing other chemical analysis is greatly appreciated.

Best regards,

Beluga123