It is critical that APIs have been manufactured to the highest possible quality in order to make sure that the final product meets specification. Amazon Filters is highly experienced in supplying productive solutions for the different parts of the API production process, whether it is the initial filtration of raw chemicals and solvents, the purification of the compound with the use of carbon or the fine quality control of the finished product.
A typical API manufacturing process involves use of highly corrosive chemicals such as concentrated acids which places considerable demands on both the filter housing and the filter cartridges used. Traditionally specialised filter housings such as those produced with an internal coating or made from exotic nickel alloys have been recommended for API manufacturing. However, neither of these options is ideal. Coatings are prone to mechanical damage and nickel alloys have limited resistance to corrosion by certain acids and some other chemicals.
To solve this challenge, Amazon Filters has developed two proprietary filter housings that can cope with these difficult applications. One of the filter housings uses Tantalum metal deposition and the second has been manufactured with an all PTFE construction. Both of these specialist filtration housings have demonstrated in multiple API manufacturing process applications a significant resistance to corrosive chemical damage.
For more aggressive API manufacturing processes that involve concentrated acids or a high temperature, the Amazon Filter range of SupaPore microfiltration cartridges can be supplied in either Halar or PTFE materials. These filters are available with ratings as fine as 0.1 µm and up to over 100 µm, so are suitable for all particle control applications.
Drawing upon their in-depth knowledge and long experience of pharmaceutical processes and applications, technical staff will be available on Making Pharmaceuticals** Stand 407 to offer advice on which filter and filtration housing is most compatible with the mixture of different chemicals and solvents used in your API manufacturing process.
Amazon Filters are fully conversant with the US FDA and European regulatory requirements for the design and use of filtration products in key pharmaceutical production areas including API manufacturing, sterile products, support utilities as well as the manufacture of creams and ointments.