|
|
|
| home > pmps > autumn 2003 > production of blow fill seal container closure systems for pharmaceutical application |
|
|
 PUBLICATIONS |
Pharmaceutical Manufacturing and Packing Sourcer
|
Blow fill seal containers are a commonly used system for pharmaceutical infusion and injection solution application, and blow fill seal packaging systems are customer specific machines. An important characteristic of the blow fill seal process is the sterile and pyrogenfree moulding of bottles or ampoules directly from the extruded PE or PP in water-cooled blow moulds with an immediate sterile filling of product, and followed by a hermetic sealing of the container in one step and under aseptic conditions in the same machine. This assures high reliability as well as product security. The flexible design of the containers, which combine integrated moulding of the head closure and in-mould coding, allows for a high degree of convenience in user handling. The technology is well-known for its very low particulate matter production and neutrality to the filling product.
The materials used to manufacture blow fill seal containers are primary packaging materials suitable for storing infusion solutions until they are administered. A closure system which will make the connection between the bottle and the infusion set or a syringe is essential. The sealing between the infusion set and the bottle is important for the closure system, as is the handling of the opening system. Additionally, an issue to be aware of is the rubber or TPE disc implemented in the bottle pack cap, which acts as a barrier product for the patient. There are many different systems on the market, and this article will concentrate on the standard Euro bottle pack cap according to the ISO 15759, exploring different types of rubber discs.
|
Read full article from PDF >>
|
|
 |
|
| Rate this article |
You must be a member of the site to make a vote. |
|
Average rating: |
0 |
| | | | | |
|
|
 |
News and Press Releases |
 |
CPhI China opens with analysis pointing to a surge in growth in 2019
Shanghai, 23rd May 2019: New analysis released ahead of CPhI & P-MEC China (#CPhIChina and #PMECChina) – co-organized by Informa Markets, CCCMHPIE, and Shanghai Sinoexpo Informa Markets – forecasts that China will continue to grow strongly through 2019/20, thanks in part to a marked improvement in its global reputation.
More info >> |
|
 |
White Papers |
 |
|
Points to Consider When Developing a TMF (Trial Master File) Strategy
Phlexglobal Ltd
Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation.
The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems.
As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
More info >> |
|
 |
Industry Events |
 |
The Universe of Pre-filled Syringes and Injection Devices
22-23 October 2019, The Swedish Exhibition & Congress Centre Gothia Towers Hotel
PDA’s Universe of Pre-filled Syringes and Injection
Devices has become the must-attend meeting for everyone
working in the field, and is now the world’s largest conference on this subject
More info >> |
|
|
