ASO Co., Ltd.

 We produce polyethylene bags used during the pharmaceutical manufacturing process.

Accordingly, there are many cases in which various preparations (in some cases sterile) directly contact our poly bags.

So, the question arises, "What are the regulations for polyethylene bags for this kind of use?

 

 For example, food packaging has regulations under the Food Sanitation Law (Notice No. 370 of the Ministry of Health and Welfare, 1959 and Ministry of Health and Welfare ordinance No. 52 of the Ministry of Health and Welfare, 1951, etc.).

There are a variety of regulations for plastic pharmaceutical containers such as containers for packaging final pharmaceuticals and PTP packages, and plastic containers for ophthalmic solutions.

 There are no stipulations for polyethylene bags that are used intermediately during the manufacturing process.

On the other hand, if you look at other countries, the USP in the U.S. and EP in Europe seem to stipulate the standard as "CONTAINERS".

 

 We have completed each of the tests such as USP and EP. However, in many cases, such as the above-mentioned polyethylene bags for use in Japan, the test standards of the Japanese Pharmacopoeia "polyethylene or polypropylene aqueous injection containers" are met.

 In addition, the guidelines for the primary evaluation of medical devices have other endpoints, such as sensitization, intradermal reaction, acute systemic toxicity, subacute toxicity, genotoxicity, pyrogenicity, implantation test, and blood compatibility. 

 

 However, there is a requirement for cytotoxicity testing in the specifications of the Japanese Pharmacopoeia for Polyethylene or Polypropylene Containers for Aqueous Injection. Cytotoxicity testing is a test that is mandatory for testing all products of biomaterials, and is also an important biological toxicity evaluation. Therefore, we believe that the above evaluation test is sufficient because our additive-free poly bags are the additive-free type of polymers alone.

 The pyrogen test and acute systemic toxicity test have been completed.

 Next, in the pharmaceutical field, we also receive questions about insoluble particulates.

 Whatever type of resin is used, insoluble particulate generation (polymer particles and additive particles) is an inevitable problem.

 We believe that the amount and type of particles are the most important.

 

 Therefore, it is important to ask whether it is only a polymer particle or additive particles are included?

 Naturally, if there the type contains additives, the amount generated will increase in proportion to the amount added and the volume of resin.

 Since all of our clean poly bags are additive-free, the particles detected will be only polymer particles.

 

 Polymer particles are difficult themes because they can be determined at the resin design stage.

 Therefore, we use resin types with the lowest possible amount of particles.