General Electric lights up Interphex
range of new products and applications for pharma manufacturing.
GE Advanced Materials has launched two new lines of silicone rubber to improve upon its existing product, Tufel II.
GE's new Tufel III is a two-component, platinum-cure silicone elastomer that can be incorporated into peristaltic pump tubing to obtain high precision and repeatable delivery of liquid in drug production lines.
"It provides high resilience and elastic memory, resulting in twice the pump life of the existing Tufel II and other non-GE elastomers," Eric Luftig, GE Silicones, healthcare industry manager told In-PharmaTechnologist.com.
"The slight increase in cost of this product is outweighed by the cost savings made when it lasts twice as long," he said.
In addition, the tubing offers low hysteresis, for flow accuracy and is transparent to allow visible flow checks.
The company is also offering a new Tufel I silicone elastomer, for manufactures to use when making pharma tubing, fluid transfer tubing, gaskets and seals.
Tufel I is based on a new catalyst technology that eliminates the mixing process step and is supplied to the customer as a ready-to-use product, thus expediting the manufacturing time and reducing costs.
"Tufel I may reduce manufacturing costs by up to 10 per cent," said the company.
Compared to the PVC that is traditionally used in pharmaceutical tubing, silicone is more flexible and can withstand high temperatures. It also lacks the plasticising agents that are used in PVC and so there is no danger of leachates.
"Silicone is a high-end, high-performance and high-purity material and should be used by pharma manufacturers who require these qualities," said Luftig.
In-PharmaTechnologist.com also spoke to GE Faunc, the company's Automation Division, to see what it had on display.
The main product featured was the company's new process analytical technology (PAT) software, hailed as bringing more efficiency to the drug production line by allowing some of the quality control and validation processes to be carried out in real-time, without having to stop production while samples are sent away to an external lab for testing.
"Until now, manufacturers have needed to do quality checks at each step in the manufacturing process, wasting precious time in production," said Ambrose.
"For example, it may take 50 days to make a drug, but only five of these days are actual manufacturing and the rest are quality control testing in a lab," he said.
The company's software solution talks to the various analytical instruments on the production line, such as a near-infra red (NIR) camera or spectrometer, and collects the data into a standard-based repository.
This data is then interfaced with GE's chemometrics software package, which contains the design specifications for the product being manufactured.
The software then checks that the critical quality attributes (CQA) of the drug, including blend, coating thickness and uniformity, are within the required specifications.
In this way, any problems can be rectified there and then, without wasting time waiting for lab results.
"The ability to define the chemical specifications of a drug while it is still on the production line has the potential to save weeks in manufacturing," said Ambrose.
"This technology also has tremendous advantages in improving the predictability of the manufacturing process," said Ambrose.
A typical installation of GE's PAT software will cost less than $10,000.
The company was also demonstrating the newest version if its human machine interface (HMI) for life sciences; iFix v.4.0.
The upgrade has been made to integrate new biometric features, such as fingerprint and iris scanning, to replace traditional password security measures.
"Life science companies are now looking for more security in their computer passwords so they can't be copied or misused," said global business director, Larry Ambrose.
"Biometric security also speeds up the validation process and reduces typing errors," he said.
The new software also integrates a new "change management" system to automatically track changes in data entry. Previously this had to be done manually.
A typical software package will cost between $2,000 and $10,000 depending on how much data is being used.
