Quarterly Dose Audits
Using dose substantiation to attain a sterility assurance level When a product or device’s basic function is to improve the health of others, you need to be certain that it’s as free of contaminants as possible. At C.G. Laboratories, we know that making sure your product is safe is your highest priority. Quarterly Dose Audits are essential to that process. We work with you to streamline the experience to make your Quarterly Dose Audits (QDA) as painless as possible. You’ve already established a sterilization dose that meets the requirements for sterility for your product type. Its specified Sterility Assurance Level (SAL). If not, we can assist you with that as well. This minimum dose needed to achieve sterility must be monitored on an ongoing basis. For most manufacturers that is quarterly. Why is this necessary? Bioburden can shift and change over time. Microorganisms
What is Package Integrity Testing?
Package integrity testing is used for shelf life studies and for looking at packages which hold sterile products that need to remain sterile and free from defects of any kind. Packaging of materials that need to be sterilized and remain in a sterile condition for a predetermined shelf life must undergo package integrity testing. This allows the package to be tested at intervals during the proposed maximum shelf life, to prove that the packaging is still providing an effective seal and protection for its’ contents, from environmental influences. Accelerated aging studies are an important part of the package integrity testing process. Accelerated aging allows the simulation of aging, in which the package is placed into an incubation chamber, at a temperature higher than room temperature. Higher temperatures in the incubation chamber allow for the process of aging a package much faster than room
C.G. Labs is now MDSAP/ISO 13485:2016 certified
What is MDSAP? MDSAP (Medical Device Single Audit Program) is a jointly leveraged Regulatory Audit recognized by 6 countries/regulatory authorities. C.G. Laboratories utilizes this certification to assist in obtaining private label licensing for Canadian Class 2 medical devices for distribution inside Canada. Benefits of MDSAP Reduction of Regulatory Audits Leverage Regulatory Resources Facilitate marketing authorization where a QMS is a prerequisite Promote consistency and predictability of Regulatory Programs Minimize medical device manufacturing disruptions due to multiple Regulatory Audits For Additional Information contact Russell Crum 817.279.1945 Ext. 1 firstname.lastname@example.org
AAMI Certified Sterilization Specialist on Staff
Did you know that AAMI has a new Certified Industrial Sterilization Specialist (CISS) certification? AAMI has developed a certification program that allows sterilization professionals to showcase their knowledge, experience, and devotion. An industrial sterilization specialist is a person who understands the principles of sterilization process development, validation, control and management as part of the manufacture of healthcare products. C.G. Laboratories has an AAMI Certified Sterilization Specialist (CISS) on staff. A CISS has expertise in the science of sterilization (including, but not limited to microbiology, physics, and chemistry), knowledge of sterilization processing, quality management systems, risk management and regulatory requirements. Recertification requirements for this certification are a combination of work experience and continuing education to demonstrate sustained competency and knowledge in the industrial sterilization field. Russell Crum has 25 years of industrial sterilization expertise and specializes in both Ethylene Oxide and Moist Heat Sterilization:
Do you need a decontamination Laboratory?
Do you need decontamination of your medical devices? What are the reasons for decontamination of medical devices? First let’s explain decontamination. Decontamination is the process by which something is rendered free from microbial pathogens. Though much of the process is similar, decontamination is different from sterilization in that it might have environmental microbes, and thus not completely sterile. Also, the item is not to be used on a patient after decontamination. Decontamination typically uses the same methods as sterilization including; liquid chemicals, ethylene oxide gas, gamma radiation, or steam autoclaving that are used by hospitals. Now why would someone need decontamination? Some reasons are… The manager of the quality department of a medical device company is responsible for the complaints of devices. Maybe there is a trend with a particular malfunction and you need to analyze these malfunctions to determine the root cause. So, analysis
DuPont Tyvek Medical Packaging Transition Project
Introduction Most people in the medical device industry are aware of the change that is occurring with DuPont’s Tyvek material. Essentially, DuPont is not changing the product, but only changing the manner in which it is manufactured. DuPont is switching to the latest flash-spinning technology in 2015. It is my belief that the majority of the CG Laboratories customers do not want to read all the detail of the testing and learn all of what DuPont has done. They just want to know the bottom line. Therefore this is designed to draw the “bottom line” for CGL customers. For those of you that just want to skip from here and read the summary- go for it! A direct link to lots of information and data is at www.areyouready.tyvek.com. Facts DuPont has been in contact with the US Food and Drug Administration and has developed a