Cleanroom Certification and Medical Device Microbiology Testing

1. Cleanroom Certification and Medical Device Microbiology Testing

2. Cleanrooms are designed to reduce contamination and control airborne particle concentrations and environmental conditions in critical areas using HEPA-filtered air and specific airflow design parameters. Cleanrooms can be overpressure or exposed to overpressure. Cleanroom certification should be performed on a regular basis to ensure that customer, industry, and regulatory requirements are met to ensure the facility is operating within operating limits.

3. Clean Room Certification Services: Our clean room certification services include documentation generated using data, TSS’s proprietary 21 CFR Part 11 compliant data collection software. A clean room test document will be delivered at the time of service. An optional formal summary report containing all test procedures, associated graphs, results and overall conclusions of the tests performed can be included and can be customized to meet your quality documentation needs. All cleanroom testing is performed by highly qualified technicians in accordance with current Good Manufacturing Practices [cGMP], Institute of Environmental Science and Technology [IEST], International Organization for Standardization [ISO], and applicable customer design specifications.

4. Role of Cleanroom Technicians: Cleanroom technicians play a key role in ensuring that contamination, humidity, and temperature are controlled in sterile laboratory and manufacturing environments. A tiny speck of dust, or even a tiny particle, can ruin a microprocessor, cell phone, or pharmaceutical product during the manufacturing process, costing a company money. Attention to detail is essential in this job. Skills are acquired on the job, on the job, or through a certification process. On-the-job training and certification in cleanroom cleaning are the classic ways to become a successful cleanroom technician. Through the certification process, technicians learn cleanroom training methods and learn the latest in cleanroom technology.

5. How to Become a Cleanroom Technician? A High School Diploma (GED) is the minimum educational requirement for entry-level jobs as a cleanroom technician. Qualifications such as her CPT Certified Professional certification program at NEBB include a bachelor’s degree in engineering and a year’s cleanroom performance testing experience, or a high school diploma or equivalent, and she has two to three years of Professional experience in cleanrooms is required. Qualities often sought by employers when hiring cleanroom technicians include communication skills, initiative, reliability, ability to lift up to 60 pounds, and previous experience in a hospital or manufacturing environment.

6. Cleanroom technicians are hired by manufacturers, laboratories, or cleanroom cleaning services to inspect cleanrooms for regulatory compliance and make any necessary adjustments. A clean room technician wearing a face mask and protective clothing tests an environment where workers assemble blisters her packs of medical equipment, prosthetics, electronics and pharmaceuticals. They use devices such as particle counters and photometers to check for contamination.

7. Cleanroom Certification Process: A certification program is an excellent way to learn the job of a cleanroom technician. The National Environmental Balancing Bureau (NEBB) is one of the well-known companies that provides training in cleanroom technology. Aspiring engineers study cleanroom performance testing protocols to ensure that the facility being inspected is within acceptable standards for research and manufacturing activities. Listen to lectures and study guides to understand how high-tech instruments and devices are used to inspect airflow systems, measure temperature, and adjust humidity levels.

8. Most certification bodies, including NEEB, limit training opportunities to individuals currently employed by a company or company with a certified cleanroom. We offer a Professional (C) certification. The certification process includes applying online, completing a NEBB course or equivalent live seminar, and passing a 100-question multiple-choice written exam. Hands-on training provide comprehensive ISO 9001 cleanroom training to new hires at company site training facilities such as C.E.R.T.S. Cleanroom technicians often start out as general maintenance workers. Familiarity with electrical and plumbing systems will help you land maintenance jobs. Conscientious and detail-oriented workers may be recruited for on-site cleanroom training and duties. In addition to their cleanroom responsibilities, they can be trained to maintain airflow systems and monitor the safety of containment cabinets that store toxic materials. Regular testing of medical devices and medicines is necessary to ensure this. The manufacturing process is still under control. Microbial test method depends on the product or component type and own quality control criteria that must be met.

9. Cleanroom Testing: • Bioburden verification ensures that bioburden test methods are valid for a collection of microorganisms present in the device. •  Cleanroom test determines how many microorganisms are present in non-sterile materials. • Is a medical device, component, or container and is performed on the product. This requires control/monitoring of the bioburden count.

10. Sterility Verification and Testing: •  Validation of sterility test methods ensures that microorganisms recovered in the presence of product under test conditions. •  Sterility testing is used to determine the presence or absence of viable bacteria microorganisms on medical devices (or parts thereof) and microbes accustomed to the validate minimum sterilization dose has achieved Required Sterility Assurance Level (SAL). •  Sterility tests are prescribed by the Pharmacopoeia and performed on the product after the aseptic process or contact sterilization process sterilization dose audit, justification and adjustment. •  Sterilization dose proof and setting studies confirm minimum values radiation dose required to achieve the required sterility assurance level (SAL).

11. Environmental Monitoring: •  For the inspection of pharmaceutical surfaces and airborne contaminants clean rooms and other controlled environments. •  Surface monitoring ensures acceptable levels of microbial population touch, wipe and rinse techniques. •  Aerial Surveillance includes non-viable (non-viable) and viable assessment (living) air pollution.

12. Medical Device Microbiology Testing: Medical Device Microbiology Testing identifies the presence and types of microorganisms in manufacturing environments, medical products, or medical devices. Microbiological testing is both a legal requirement and a risk mitigation strategy for aseptic manufacturing environments. Microbiology-specific regulatory tests include microbial enumeration test, particle analysis, yeast analysis, antifungal activity evaluation, growth promotion test, microbial threshold test, zone of inhibition test, water analysis, bacteriostatic/bacteriostatic test, bacterial identification, yeast Identification, fungal identification, Gram-negative staining, product inoculation, biomarker testing, and BI incubation time reduction studies. Since medical devices and products must be sterile for use on the human body, microbiological testing is essential to prevent product contamination during use.

13. There are two ways to create a sterile medical device. • First, a terminal chemical or heat sterilization process is applied to the packaged medical product or device to kill any live microorganisms picked up during the terminal sterilization manufacturing process. • The second method uses aseptic processing throughout the manufacturing process of a medical device or product. Aseptic processing requires the exclusion of microorganisms from the manufacturing process. • Microorganisms must therefore be prevented from entering open containers and product materials during aseptic processing. Microbiological testing is therefore used to monitor cleanrooms and facilities that manufacture products that involve aseptic processing. Source: https://insighthow.com/cleanroom-certification-and-medical-device-microbiology-testing/