Save Startup Time And Money Using Contract Testing Services
What is a contract testing organization?
Contract testing is a form of outsourcing (outside resourcing). As the name of the term “contract testing” implies, a contract testing company creates an agreement (contract) with another business (company A) to complete a series of tests. Thus, company A hires the contract testing organization to complete regulatory testing activities that they can’t do in-house or don’t wish to achieve internally. Utilizing the services of a contract testing company can supply a host of benefits. For example, contract testing organizations ease the path to getting a FDA-regulated medical device approved for patient use. Examples of manufacturers that must list their devices with the FDA can be found HERE. Overall, a great contract testing organization saves business startup money and provides updates on new FDA regulations including FDA regulation of medical devices. Read more to see how contract testing companies can save startup time and money.
What are the benefits of using a regulatory contract testing organization?
Many contract manufacturing benefits overlap with contract testing benefits. There are a few different reasons to use an outside company to support regulatory testing:
#1: Cost savings
Let’s face it. Medical device development costs are high. Often companies must be frugal with their business startup money. With contract testing organizations, companies save money instantly because they do not have to pay startup costs for testing equipment or facility space. Additionally, companies save money on skilled technician hiring, wages/benefits, and training. As contract testing companies serve multiple customers, they purchase testing materials (such as biological standards) in bulk. Thus, contract testing organizations can often offer reduced testing material costs. While all of these benefits are obvious for startups and small companies with limited startup capital and resources, large corporations also benefit from using contract testing through outsourcing any regulatory testing needs outside of their core competencies.
#2: Advanced technical skills at your fingertips
Medical device companies can use the contract tester’s engineers, scientists, regulatory experts, and technicians with years of experience to their advantage. These experts will know which quality assurance and biocompatibility tests to run for your unique products. Experts will also know new FDA regulations including FDA regulation of medical devices. New FDA regulations are released each year and the importance of tracking new FDA regulations for new medical devices and currently marketed devices cannot be understated. Nobody wants their device to be removed from market or to have their marketing approval delayed due to a new FDA regulation of medical devices or other products.
#3: Instant access to GMP quality facilities
Facilities that are certified for Good Manufacturing Practices (GMP) require ongoing environmental monitoring to maintain certain levels of sterility and excellence. Through utilizing a contract testing organization, you gain instant access to GMP quality testing facilities and circumvent the headache of startup facility costs and lengthy certification processes. Business startup money doesn’t grow on trees and companies can save business startup money through avoid the upfront costs of building, certifying, and managing a GMP quality facility.
#4: Allows outsourcing business to focus on branding depth
With outsourcing regulatory testing and other business components outside of a company’s expertise, businesses can focus on their core competencies and building their corporate brand. Thus, new companies can focus on establishing depth with their business startup money over breadth.
#5: Time savings
Businesses do not need to hire staff, train technicians, reallocate personnel or acquire testing equipment with a contract testing organization. Instead, companies have access to on-demand contract testing services that parallel medical device manufacturing, branding, and other product development activities. Further, utilizing contract testing organizations in countries with your device’s target market often speeds up the regulatory testing process.
While not all-encompassing, medical device regulatory testing has the following testing stages and hurdles:
Save Startup Time and money With Bioburden, microbiology, and bacterial endotoxin testing
Bioburden testing measures the viable organisms present in a sample. The total viable organisms present is expressed as a total viable count. This total viable count (represented as CFU’s) provides a value for the microbial contamination level within a particular sample. Combined bioburden and microbiology testing can identify what types of live microorganisms are present in a sample from a product, package, or manufacturing environment. Bioburden testing and microbiology are not synonymous. Instead, bioburden testing is a general CFU measurement, while microbiology testing identifies the specific types of live microorganisms in a sample and quantifies them. Specific regulatory testing for microbiology may include assays such as microbial enumeration testing, particulate analysis, yeast analysis, antifungal activity assessment, growth promotion testing, microbial limits testing, zone of inhibition testing, water analysis, bacteriostasis-fungistasis testing, bacteria identification, yeast identification, fungi identification, gram-negative staining, product inoculations, biological indicator tests, and BI incubation time reduction studies. Bioburden and microbiology testing follow the methods outlined in USP 60, USP 61, and USP 62. Accurate bioburden testing saves startup time and money through identifying potential contaminants as soon as possible.
Bacterial endotoxin tests (BETs) use an assay known as the limulus amoebocyte lysate (LAL) test. Bacterial endotoxin testing is an in-vitro pyrogenicity test. Furthermore, a BET is the most common, easiest, and cheapest pyrogenicity test for medical devices and products. BET testing is separate from rabbit pyrogen testing, which is rarely needed for regulatory medical device testing. LAL is an extract of blood cells from the Atlantic horseshoe crab. LAL detects the LPS of the cell wall of gram-negative bacteria, even if these bacteria are dead. LAL detects LPS through clotting and gelling in the presence of LPS, allowing for precise calculations to be made as to the concentration of endotoxins in a sample. USP 85 governs BETs. Save startup time and money with accurate bacterial endotoxin testing, which ensures your products meet FDA regulations for medical devices.
Cytotoxicity testing
Cytotoxicity testing evaluates the biological reactivity of mammalian cells and tissues to contact with elastomeric plastics and other polymeric materials that will come in direct or indirect patient contact during medical device or product use. Cytotoxicity is significant as it evaluates the biological effects of a sample’s leachable chemicals. The types of cytotoxicity testing to perform for your medical device or product depend upon the final product, the final product’s intended use, and the materials the final product is made of and packaged within. In-vitro methods of cytotoxicity testing include direct contact, agar diffusion, and elution testing. In-vivo methods of cytotoxicity testing include intracutaneous injection, systemic, and implantation testing. Most medical devices and products will only require in-vitro cytotoxicity testing. Reusable devices may require cytotoxicity testing for initial use and device use following recommended reprocessing. Cytotoxicity testing follows the methods outlined in USP 87 for in-vitro testing and USP 88 for in-vivo testing.
Sterility testing and validation
Sterilization is critical for medical devices as it removes, kills, or deactivates microorganisms existing on or within a product. Sterility can be assured using a validated sterilization process operated under current good manufacturing practices (cGMP). Sterilization validations are tests that statistically prove and verify that a sterilization process can consistently sterilize medical devices or products under “worst-case scenario” conditions. An acceptable level of contamination risk for most items is the probability of contamination for one in a million products. However, sterility criteria may be more stringent or lax depending upon the intended use of the medical device or product. Common sterilization modes are dry heat sterilization, steam sterilization, gaseous sterilization, and radiation sterilization.
In order to perform successful sterilization validations, a medical device’s bioburden level (microbial contamination range) must be known. Further, environmental monitoring is used to ensure that the product’s manufacturing environment meets acceptance criteria and does not alter the bioburden levels of manufactured products.
Suppose a heat-sensitive product undergoes gaseous ethylene oxide (EO) sterilization. In that case, the FDA requires ethylene oxide residual testing to be performed if your device will be in contact with the patient. EO sterilized devices are placed into one or more of three exposure categories based on the duration of contact a medical device has with a patient. These categories are designed to protect patients against EO-related cellular toxicity that can cause varying degrees of illness and tissue damage. The classes of EO exposure are limited exposure (less than 24 hours), prolonged exposure (1 day to 30 days), and perpetual exposure (lifetime limit). Each category has specific limits (in milligrams) that must be met. You can find the specific EO and ethylene chlorohydrin residual limits for each exposure category HERE. ISO 10993 governs all EO residual testing. Save business startup money through selecting materials that can be easily sterilized with inexpensive methods (such as steam sterilization).
Package integrity testing
Package integrity testing has to do with testing how well a package stays whole and undivided to keep wrapped objects protected and sterile. Package integrity testing involves both leak testing and seal quality assessments of your packaging system. For additional information on specific package integrity tests, see our articles on seal strength testing, bubble emissions testing, and dye penetration testing. Package integrity testing is governed by a variety of ASTM guidance documents as well as USP 1207.
Stability testing
Stability testing covers the physical storage of packages over time (under normal and accelerated aging conditions) and tests for sterility, toxicity, chemical stability, physical stability, functionality, and therapeutic efficacy at various points during product storage. Stability testing is used to determine the expiration date for product use and is covered by various ASTM guidance documents.
Summary
Overall, contract testing is a form of outsourcing where a third-party regulatory testing company is hired to complete activities that cannot be accomplished internally. Utilizing the services of a contract testing company can supply a host of benefits, especially to startups or small companies. These benefits include cost savings, time savings, access to advanced technical skills outside a company’s expertise, and other benefits like GMP quality facility access. While not all-encompassing, medical device regulatory testing has the following five testing stages and hurdles: 1) bioburden, microbiology, and bacterial endotoxin testing, 2) cytotoxicity testing, 3) sterility testing and validation, 4) package integrity testing, and 5) stability testing. Contract testing companies, like Ethide Labs, can provide testing services and packages that will supply you with the data you need to get your unique medical device FDA approved.
Ethide Labs is a contract testing organization specializing in Microbiology Testing. Ethide Labs also offers Bioburden Testing, Bacterial Endotoxin Testing, EO Residual Testing, Sterility Testing, Cytotoxicity Testing, Environmental Monitoring & Package Integrity Testing services for medical device companies and allied industries. Ethide is an ISO 13485 certified facility.
References
Contract Manufacturer. Wikipedia. 2021.
International Organization for Standardization. Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals. Geneva (Switzerland): ISO; 2008. (ISO 10993-7:2008).
Michael J. Akers. Sterile Drug Products Formulation, Packaging, Manufacture, and Quality. Drugs and the Pharmaceutical Sciences. Informa Healthcare. 2010.
United States Pharmacopeial Convention. <60> Microbiological Examination of Nonsterile Products- Tests for Burkholderia Cepacia Complex. Rockville, MD, USA. 2021. (USPC <60>).
United States Pharmacopeial Convention. <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests. Rockville, MD, USA. 2021. (USPC <61>).
United States Pharmacopeial Convention. <62> Microbiological Examination Of Nonsterile Products: Tests For Specified Microorganisms. Rockville, MD, USA. 2021. (USP <62>).
United States Pharmacopeial Convention. <85> Bacterial Endotoxins Test. Rockville, MD, USA. 2021. (USPC <85>).
United States Pharmacopeial Convention. <87> Biological Reactivity Tests, In Vitro. Rockville, MD, USA. 2021. (USPC <87>).
United States Pharmacopeial Convention. <88> Biological Reactivity Tests, In Vivo. Rockville, MD, USA. 2021. (USPC <88>).
United States Pharmacopeial Convention. <1085> Guidelines On The Endotoxins Test. Rockville, MD, USA. 2021. (USPC <1085>).
United States Pharmacopeial Convention. <1115> Bioburden Control of Non-Sterile Drug Substances and Products. Rockville, MD, USA. 2021. (USPC <1115>).
United States Pharmacopeial Convention. <1116> Microbiological Control & Monitoring of Aseptic Processing Environments. Rockville, MD, USA. 2021. (USPC <1116>).
United States Pharmacopeial Convention. <1207> Package Integrity Evaluation- Sterile Products. Rockville, MD, USA. 2021. (USPC <1207>).
United States Pharmacopeial Convention. <1211> Sterility Assurance. Rockville, MD, USA. 2021. (USPC <1211>).
