Aseptic Technician Jobs Require Specific Experience Of Aseptic Techniques
Aseptic technique is a critical aspect of how the pharma and medical device industry operates. It involves using specially designed equipment and strict requirements to maintain sterile conditions during manufacturing processes, storage, distribution, packaging, sterilization and beyond.
The training programs that offer this unusual trade vary in duration and scope. The best place to start research is with the International Society for Pharmaceutical Engineering at http://www.iseppharma.org/indexEN-US/, which lists all the accredited schools in North America, Europe and Asia Pacific. Typically the U.S. programs last eight months, while in Europe they are semester-long. Canada and Australia have one accreditation authority for the whole country, namely the National Association of Aseptic Processing Technicians (NAPPT) at http://www.nappt.ca/indexEN-US/, which has a comprehensive listing of all schools and training programs available in Canada and is also a good place to start on your search for information on such programs outside North America, Europe or Australia/New Zealand.
What is there to know about this unusual field?
1. Aseptic technicians must be knowledgeable bionutritionists and bioengineers in the case of pharmaceuticals, if they are to work in the industry safely and effectively.
2. The American Society for Pharmacological Sciences says that, "The need for these technicians is dependent on the extent to which sterile technique is integrated into the manufacturing process being used." The only way to achieve this desired outcome is through teaching and practice. It's not exactly a "nice-to-have" skill but it's still important.
3. Training programs in the U.S. and Canada require that the courses in sterile techniques be applicable to pharmaceuticals though some courses offered in other countries may not.
4. As aseptic technicians gain experience, they are also able to choose from an increasing number of specialties such as fabrication or automation. Some of the more advanced training programs also allow students to specialize in production improvement and auditing, providing them with a broad spectrum of career options.
5. Aseptic technicians must have strong analytic and critical thinking skills and excellent manual dexterity, as well as a general knowledge of materials technology and mechanical principles. These are all important traits for anyone to have.
6. Aseptic technicians spend most of their time in a shop, so many of them need to be able to drive a car and operate power tools in order to move materials around and perform other tasks.
7. They must be able to interpret the processes involved, from raw materials to finished product and everything in between, as well as what's required for each step of the process, from inspection and sanitation requirements through the final packaging process.
8. Aseptic technicians must also understand how the regulatory system related to healthcare works on both federal and local levels; however there is no requirement that they be licensed or authorized by any governing body or agency at any level.
9. For example, the Food and Drug Administration (FDA) of the United States has not recognized aseptic technicians as official healthcare professionals, but this position may change in the future.
10. Aseptic technicians are highly skilled people in their trade, but they aren't outfitted with any particular occupational license by any governing agency such as the FDA or Occupational Safety and Health Administration (OSHA).
11. These individuals also don't have to go to school or acquire any professional credentials like pharmacy technicians do.
12. For this reason, many experts believe that aseptic technicians are not addressed in any body of law or regulation and are therefore largely undefined as professionals.
13. Moreover, aseptic technicians aren't specifically included in the International Standard Organization (ISO) 14020:99 standard, which is called "Aquatic Hazard Management." The ISO is a network consisting of 163 countries that enables the exchange of international technical information on industrial standards, with the intent to be able to ensure product quality by standardization across national borders. The most recent definitions of an aseptic technician come from the FDA's website:
14. In order to work as an aseptic technician, individuals must follow specific rules and regulations. For example, they under no circumstances may work for an employer or perform aseptic techniques for a pharmacy.
15. The term "a" means "no," whereas the term "septic" means a microbiological process that causes disease.
16. Aseptic technicians are often called "process technicians." This refers to their role in the production process and is not only used in industry but also by government agencies such as the FDA, Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA) and other agencies who oversee healthcare facilities and operations.
17. They may also be called "industrial hygienists" or just simply "hygienist." According to the FDA:
18. It is important to understand that the term "aseptic" means that the product was produced in a way that it does not contain any pathogenic microorganisms, and any non-sterile products must be pyrogen free.
19. Diagrams courtesy of www.tradenutrition.co.uk .
20. As you can see from the diagram, the aseptic process is an integral part of manufacturing pharmaceuticals, biologics and medical devices; indeed, many of these items would not be possible to manufacture without the worker knowledge and skills required by this unusual profession.
21. In some cases, these items require sterilization in order to prevent contamination by biohazards. The aseptic process is complex but it is also essential to the success of any company manufacturing pharmaceuticals or medical devices.
22.
23. Aseptic processes are health-driven and therefore ensure that a consumer receives products that meet each country's regulatory requirements for quality and safety as well as consumer protection laws established to protect both manufacturer and consumer alike.
24. In the U.S. and Canada, for example, the cGMPs and cGTPs are the regulatory requirements in place for manufacturing quality and safety.
25. This diagram is courtesy of www.tradenutrition.co.uk .
26. The FDA defines this as: "The science of measuring and monitoring conditions and factors affecting the quality of pharmaceuticals, biologics, medical devices or consumer products after they have left their control."
27. It's an important consideration whether a product can be classified as a drug (in which case it is highly regulated), a medical device (another highly regulated industry) or consumer product (which are typically regulated by OSHA).
Conclusion
28. In the United States and Canada, there are clear differences between a pharmacist and an aseptic technician and it is important to know these differences in order to protect yourself from fraud.
29. Pharmacists must be licensed by the state to practice their profession after graduating from accredited schools approved by either the Pharmacy Board of California or Pharmacy Technician Certification Board. These schools can vary greatly, but in general will have required courses in chemistry, physiology, pharmacology and professional practice, as well as health-related courses such as nutrition and human anatomy. Students must take an exam in each of these areas before graduation.