Back then aseptic processing never seemed to change like the way it has today. Technology has evolved the procedure in ways that no one could have ever imagined. However, the changes still need to occur from what was done in the 70s to have better machines and quality products that are bacteria free in the pharmaceutical industry.
That is the reason why Steriline manufactures only the high-quality machines and robotics. The firm is determined to see their customers happy by giving them what solves their problems. Steriline is a European company that majors on aseptic processing in the pharmaceutical industry.
The company supplies diverse products to different countries worldwide. Steriline ensures it manufactures durable and efficient machinery that leaves no room for errors. The firm aims at becoming the number one manufacturer for aseptic processing machinery.
Aseptic processing sector has seen dramatic changes since the PDA reviewed industry expectations and practices. There has been advances in regulatory updates, altered perspectives and equipment design. This guide has some of the major changes that have happened in the past in the field of aseptic processing.
Significant Changes in the Process
The superb progress in aseptic processing has been outstanding but one thing still baffles the authors, it is believed that contemporary microbiological methods can be used to recover all microorganisms with very minimal detection rate. Here are some of the issues to consider when thinking of aseptic processing.
Many people still think that biologics and drugs cannot undergo sterilization process to be stored in the final containers. That means most of the goods labeled sterile and parenterals were produced via aseptic processing. Experts need to rethink the sterilization processes and change the status quo for some of the pharmaceutical products.
For about 40 years, sterilization has been all about the destruction of microbial and also the inactivation of high population, highly resistant biological indicator. This idea resulted to an unintended consequence that made terminal sterilization more tiring and difficult. Some experts became overly aggressive and implemented unnecessary approaches which only exposed the pharmaceuticals to severe and extreme conditions. Such conditions only affected the product’s quality even the more. That made the sector rely on aseptic processing over the terminal sterilization.
Sterility was a Shifty Goal
For around two decades the regulatory committees and the industry have been at logger heads regarding aseptic processing. The dilemma comes from a logical point of view that no party seems to agree with. However, the notion is not scientifically right. The idea has it that every lot of products that were manufactured via aseptic processing has sterile material only. The literal meaning of sterile is there is no chance for uncertainty in the outcome. However, in this context it means the product is free of viable organisms. When the aseptic processing is below the practical assay proficiency, the risk assessment is not pertinent to the capability to measure microbes.
Introduction to the advanced processing systems has brought about a new understanding in the industry. One that define a revamped reality accepted by some while others reject the idea. Sterility can only be achieved via implementing the proper practices that give products the protection they require from contamination.
In this context sterility can only be described as the confidence in the final product after going through several contributing systems. That means improvements in the aseptic processing processes creates a conundrum. The initial microbial tests are no longer used since contamination levels are so low that they cannot be detected.
This is a major fix that the modern microbiological methods cannot address. Today advanced aseptic processing is robust meaning, in any well-developed system the issue of contamination is never a big deal. To some, contamination is easily controlled to a point where it is not relevant. However, the current regulatory expectations and beliefs fixate on testing using little utility methods and sampling. Firms are also encouraged to increase the use of these parameters.
Probably the industry made a mistake in labelling these products “sterile.” In as much as no harm has come from this ‘error’ no aseptically produced product has been proven sterile.
Steriline on Robotics
Robotics is one issue that has to be mentioned any time one talks of aseptic processing. Steriline has been on the edge trying to manufacture robots that will make the entire process a success and quite fruitful. As technology evolves, so did the company see the need to merge the machines and electronically controlled equipment to perform tasks involving harmful and dangerous compounds.
Robots are also much faster with less effort taken to cleanse the vials and glass. Some of the remarkable robotics by Steriline include robotic vial capping machine, robotic vial filling machine, robotic tray loader and robotic external decontamination machine.
Aseptic processing has had several changes and adjustments over time. It has also had its fair share of problems with involved parties. All in all, the pharmaceutical industry is growing and there is need to bring on board better methods to clean the vials, load the trays etc. Steriline is always looking to improve the robotics offered such that they become even more efficient.