Possible Problems With Medicinal Glass Bottles

We know that the medicinal glass bottles are directly in contact with the drug, directly acting on the human body, so the quality requirements are relatively high, the medical glass bottles may appear a lot of problems, the details to share with you.For more information on bottles, click here

 

I. Solution clarity and color, visible foreign bodies, insoluble particles

 

Packaging containers due to cleaning and high temperature sterilization and other factors such as liquid medicine and prescription caused erosion of glass material, resulting in solution clarity and color, visible foreign bodies, insoluble particles and other problems.

Clarity refers to the clarity of the liquid, which is checked for visible foreign bodies and visible turbidity. There is a difference between visible foreign bodies and insoluble particles. Both visible foreign bodies and insoluble particles are ineffective insoluble substances in injection. The main differences are as follows:

 

① Visible foreign bodies are visible to the naked eye, and the particles also include small particles invisible to the naked eye;

② Different inspection methods: Visible foreign bodies can be checked by the naked eye or equipment, but particles can only be checked by instruments;

③ Different objects of examination: foreign bodies must be examined for all injections, and particulates are mainly for intravenous injections;

④ Prerequisite: particle inspection objects must first be visible foreign body inspection qualified products;

⑤ Different particle size: visible foreign body is gt; 50 μm particles, the particle is gt; 10 μm particles, visible foreign bodies are usually examined by lamp detection method.

 

2. take off a piece

 

The stripping of the glass, what's called a shimmering sheet suspended in the liquid, occurs when the glass erodes and the drug comes into contact with the glass,A certain reaction occurs at the interface of the two, forming an insoluble silicate material, under the action of internal stress or thermal expansion, peeling off from the glass surface, forming the so-called stripping.

3. adsorption

 

In addition, some drugs in the glass infusion bottle adsorption phenomenon, especially for biological agents, this problem may be more serious. Adsorption is a shadow.The content of the drug decreases its potency. For example, some studies have shown that the glass infusion bottle can have a certain absorption effect on insulin, the test results.The results show that when the pH of insulin solution is 5, the adsorption effect is large, and the adsorption rate is about 30%. It was found that with the increase of pH value (pH> 5), the absorption of insulin gradually decreases.

4. pH value change

Pharmaceutical packaging materials may affect the pH of the solution, resulting in changes in the pH of the product during preparation or storage.