At Mediatech, we offer competitive pricing and unmatched quality. In our cGMP facility, highly automated manufacturing processes and strict Quality Systems enable us to guarantee low endotoxin levels for our liquid and powdered products and ensure that our liquid products meet the most rigid Sterility Assurance Levels (SAL). Endotoxin levels are a “Release Specification” and not “For Information Only.” The endotoxin release specification for standard cellgro® cell culture media and salt solutions is less than or equal to 0.25 EU/mL. Mycoplasma testing is also a “Release Specification” on all complete media and salt solutions.

cGMP:  Mediatech follows current Good Manufacturing Practices (cGMPs) prescribed by the FDA (21CFR; Part 820). This requires the formalization, validation, standardization, and documentation of all operational procedures, systems, functions, facilities, materials, and equipment. Mediatech has established Standard Operating Procedures (SOPs) for all its manufacturing and quality procedures. The company regularly validates its equipment and processes to ensure that they continue to meet their specified design criteria. In addition, internal quality assurance audits are performed to verify that manufacturing and quality control functions are being properly executed.

Sterile Label:  Mediatech is in compliance with FDA Guidelines for Class I Medical Devices, and the revised FDA “Guidelines for the Manufacture of In Vitro Diagnostic Products” (January 1994) for “Sterile” labeling. Like other products labeled for IVD use, Mediatech’s products are not intended for human or animal therapeutic use.

SAL <10-3:  Products are prepared by an aseptic process for which each step has been validated to ensure that all Mediatech products are equal to or better than the industry’s Standard Assurance Level (SAL) of <10-3 (i.e. demonstrates a manufacturing fill process of no more than one random contaminant per 1,000 units).

To ensure accuracy in product formulation, Mediatech created and implemented the Integrated Bar Code User System (IBCUS) in 1997. IBCUS is a proprietary bar code system that combines a computer-based weighing system with human operation and verification. The electronic documentation methods, which incorporate integration of a bar code for information transfer via electronic scanning of the data process, verify that all of the appropriate chemicals are added at the specified weights listed on each product’s unique formulation batch record. This revolutionary procedure offers dramatic improvements over manual systems by decreasing the probability of human error in both the weighing and documentation processes.

Mediatech prides itself on its testing requirements. In designing our internal facility and quality systems, Mediatch incorporated many of the principles developed by the pharmaceutical industry, including the use of WFI quality water, testing of raw materials, in-process monitoring, and extensive testing of the finished product. To verify that in-process controls have served their designed purposes, extensive tests are conducted on finished products to ensure that they meet the company’s stringent release criteria. Quality Systems obtains samples of each lot of finished product in accordance with The latest edition of the U.S. Pharmacopoeia and cGMPs. These samples are selected using a computer-generated random number program and are rigorously tested according to functional, biological, and physicochemical properties and chemical attributes.