All manufacturers of sterile medical devices are responsible for validation and constant monitoring of the sterilization process. Whether they sterilize in-house, or with an external contract sterilizer, the responsibility for assuring that process output consistently meets its predetermined specifications remains with the manufacturer; it cannot be delegated. Compliance with international sterilization standards, therefore, is critical for the continued success of the manufacturer.
The vast assortment of medical devices currently manufactured presents an infinite number of unique product/packaging characteristics all of which must be identified and evaluated for their potential to affect the sterilization process. Starting with the concept of a new device and continuing throughout its development and production, the manufacturer must make continuous critical evaluations such as:
design specifications and use of clean rooms; routine monitoring and control of manufacturing equipment and the environment; biocompatibility of select materials; compatibility of device design, construction, and packaging with available sterilization methods - ethylene oxide, gamma, electron beam, steam; No standard could ever be written so as to specifically address each and every medical device. As a result, process validation and control requirements are written in a generic fashion. Manufacturers are then responsible for taking these 'general-purpose' requirements, correctly interpreting their intention, and applying them on a case by case basis to each and every device they intend to manufacture. To successfully do this requires an intricate understanding of the regulations and this can only be achieved through experience.
Quality Solutions, Inc., and its network of affiliated consultants, offers technical services covering all facets of medical device sterilization and the related laboratory services. Our knowledge and training come from direct industry experience as well as extensive involvement in AAMI standards committees. Whether a manufacturer wishes to construct an in-house sterilization operation, retrofit an existing sterilizer, arrange the selection and validation of an external contract sterilizer, or routinely monitor sterilization services, our experience in these fields assures that the quality of process output receives top priority. Being hired directly by the manufacturer, there is no chance that we will suggest anything but what is best for the manufacturer.
If a device is marked sterile and later found not to conform to its predetermined specifications for
sterility assurance, it is considered adulterated and may trigger an expensive recall. Sterilization is, therefore, the last critical manufacturing process prior
to product release. In spite of the critical nature of the process, most manufacturers either cannot afford to hire an expert sterilization manager, or cannot
justify the expense due to the sporadic nature of validation needs and the limited number of sterilization loads that are processed each week. Many compromise by
assigning critical sterilization management duties to a staff member who, while possessing the educational background, may lack the hands on regulatory and
operational experience. Many decisions, such as process validation design, process development or modification, and laboratory testing are often made with input
from the very vendors supplying the services. Urgent situations, such as sterility failures, dose audit failures, process optimization, product and/or process
equivalency, bioburden spikes, load configuration modifications, and packaging changes are not fully evaluated before the solution is selected. While experienced
vendors strive to make recommendations that comply with current standards, they cannot avoid protecting their own business interests. The policy of many service
and material vendors dictates advocating de minimus compliance with current written standards, i.e., minimum regulatory protection. For certain device families,
complying with the minimum regulations does not automatically translate into the most scientifically sound process. Everything a manager needs to know about
sterilization process validation and routine control cannot be learned by reading six pages of standard requirements. For the serious manufacturer we advocate
regulatory compliance coupled with good science learned through hands on experience for the ultimately business protection.
Rather than delegate sterilization management to an inexperienced or overworked staff member, contract with us for a comprehensive program of sterilization assurance services. To most effectively outline our services, the following is a program we would suggest for a start up company intending to design, produce and market a new device.
Initial site visit to review the product family details and manufacturing environment. Establish lines of communication with key members of the management team via telephone, fax, email. Conduct training seminars with key employees covering biocompatibility, bioburden, manufacturing environment, sterilization, major regulatory concerns. Assist with the selection and start up of a clean room for device production. Establish an in-house laboratory, or select a qualified contract laboratory, and perform a full GLP audit. Review product design concept and proposed materials for biocompatibility evaluation. Establish written program and standard operating procedures for biocompatibility test requirements each time a change in material occurs. Provide the device design team with relevant information regarding all available sterilization methods in order to select most compatible materials. Select the most appropriate sterilization method. Design and install in-house sterilization system, or evaluate all potential contract sterilization service providers. Select contract sterilization service provider, negotiate service contract, perform complete GMP audit of the facility. Design and perform sterilization process development; design and execute sterilization process validation protocol. Specify all sterilization related product and packaging testing. Generate the sterilization validation final report, routine processing specification, and all standard operating procedures necessary for routine sterilization. Establish a sterilization compliance program in which sterilization device history records are sent to a consultant's office for review and approval. Perform process deviation investigations to determine probable cause, suggest corrective action, evaluate need to resterilize. Perform sterility failure investigations to determine probable cause, recommend corrective action, and determine the impact on the process validation. Perform study and develop protocol to allow adoption of new products and/or packaging configurations into previously validated sterilization process. Schedule and perform annual revalidations. Demonstrate process equivalency in additional sterilizers through reduced microbiological validations.
Using our services not only assures you maximum regulatory compliance and good science based on experience, but it also makes good business sense. By establishing a business relationship with any of our off site consulting firms we can assume the role of providing all the necessary input and management expertise for one or more of the phases in device development and/or production. Regular communication with us, through the use of periodic site visits, conference calls, email, or faxes, allows us to follow the daily progress of the selected portions of your manufacturing process. This type of relationship allows you to acquire and implement state of the art management expertise for select tasks, without having to unnecessarily burden your payroll. Depending on the production volume, a medical device manufacturer may be able to contract with us for as little as one day a week, or less, during which we provide our services. You gain access to expert resources without the expense of full time employment.
Contact Information:
Paul J. Sordellini
25 Drexel Hill Drive
Kendall Park, NJ 08824 USA
Tel: 001.908.884.8845
Email: Quality Solutions