SPG’s Production Classification 2022-04-26 14:44:58.029
I. Clear and amber moulded glass vials for injection type I,II,III, sizes from 5ml to 100ml: Glass containers for pharma use are glass articles intended to come into direct contact with pharmaceutical preparations. The hydrolytic stability of glass containers for pharma use is expressed by the resistance to the release of soluble mineral substances into water under the prescribed conditions of contact between the inner surface of the container or glass grains and water. According to the relevant chapters specified in CP, USP, EP, the hydrolytic resistance is evaluated by titrating released alkali, based on the hydrolytic resistance, glass containers are classified in three types: Type I glass containers are suitable for most products for parenteral and non-parenteral uses. Type II glass containers are suitable for most acidic and neutral aqueous products for parenteral and non-parenteral uses. Type II glass containers may be used for alkaline parenteral products where stability data demonstrate their suitability. Type III glass containers usually are not used for parenteral products or for powders for parenteral use, except where suitable stability test data indicate that Type III glass is satisfactory.
Products Common Packaging Style 2022-04-27 14:47:03.796
As for amber bottles and infusion bottles packaging method,we use polyethylene shrink wrapped,this packaging can be used for all containers,small and large.Then packing tray,the packaging of containers for pharmaceutical use must ensure both glass containers’ protection and smooth operation on the end-user’s filling lines.
The term weatherization (or “bloom”) refers to a milky, hazy or crystalline (snowflake) residue on the inside of soda-lime glass.Although at worst an aesthetic issue, the phenomenon is often a concern for customers. As a result, salespersons must be ready and able to address specific customer concerns regarding this problem. Specifically, Salespersons must be aware of the chemical processes involved in the formation of weatherization, as well as the environmental conditions in which it is most likely to occur. Fortunately, the effect of weatherization is often minimal upon the overall quality of the glass, (although certain issues may arise regarding the pH levels of the content of the containers, depending upon specific chemical formulas). Since weatherization is often easily treated, a thorough understanding of the cause of weatherization will allow salespersons to address customer concerns in an effective manner. Ideally, customers should be made aware of this phenomenon, its causes, as well as treatment methods prior to purchase so as to avoid issues at a later date.
Bubbles are visible gas inclusions in glass, which not only affect the appearance quality of products, but also affect the transparency and mechanical strength of glass. The size of the bubbles in the glass ranges from a few tenths of a millimeter to a few millimeters. According to the size, the bubbles can be divided into gray bubbles (diameter <0.8mm) and bubbles (diameter>0.8mm).
Type I glass is more stable in surface structure because of their high hydrolytic resistance and less alkaline ion precipitation,so type I molded bottles are widely used in biological products,blood products and pH-sensitive drugs.Type I molded bottle is borosilicate glass,its low thermal expansion coefficient of product has a high resistance to quench and heat;in addition,its physical strength Degree and mechanical properties are much higher than ordinary soda-lime glass and tube products,in the cleaning,drying,freeze-drying,sterilization links broken rate is low.
ISO 9001:2008 Standard,ISO 14001:2004 Standard,OHSAS 18001:2007 Standard,ISO 15738 Certificate,LABORATORY ACCREDITATION CERTIFICATE
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