Custom Processing

Process Definitions

Use Table Below to Complete the Custom Cleaning Specification Form


ProcessDefinition        Common Applications  Typical Certifications
Depyrogenation, 
validated 3-log reduction		 The destruction and removal of endotoxins. Endotoxins are fever producing substances commonly found in the cell wall of certain bacteria. Depyrogenated products have reduced endotoxin content by at least 99.9% or 3 logs. Injectable or parenteral drugs, Lyophilization, Final packaging prior to drug delivery, stability studies, clinical trials Certificate of Process
Certificate of Analysis
(USP 85)
Silanization Silanized products have been treated to neutralize active sites in glassware. This process allows materials to remain stable and prevents them from reacting with the glass surface. It also prevents the components of the glass from leaching into the samples. Proteins, assays of blood serum, pharmacological assays of therapeutic drugs Certificate of Conformance,
Certificate of Process
Siliconization Siliconized products are physically coated with a medical-grade silicone emulsion to prevent sample material from reacting with the glass container. Proteins, assays of blood serum, pharmacological assays of therapeutic drugs Certificate of Conformance,
Certificate of Process
TOC process Total organic carbon (TOC) is a measure of the amount of carbon covalently bound in organic molecules in a water sample. EP Scientific TOC vials are cleaned and certified to contain fewer than 10ppb TOC as background. Validation of water systems, equipment validations, cleaning validations, and monitoring low levels of organic contaminates in numerous applications Certificate of Conformance – TOC
Particulate
Cleaning		 EP Scientific uses high-purity 17 Meg-ohm, electronics-grade water filtered to sub-micron levels for the particulate cleaning process. This highly aggressive, low particle water is heated and used for cleaning processes. Numerous applications in the pharmaceutical, biotech, medical, semiconductor industries, and anywhere cleanrooms or controlled environments are utilized Certificate of Analysis
(USP 788)
Irradiation Application of a radiation dose sufficient to destroy all viable forms of life. A radiation dose sufficient to destroy all viable forms of life including bacterial spores, is applied to an acceptable sterility level (SAL). A typical radiation dose is 25-40 kGy, which produces the required SAL of 10-6. EP Scientific gamma sterilizes glassware, stoppers, seals and certain caps and plastic bottles. Injectable or parenteral drugs, lyophilization, final packaging prior to drug delivery, stability studies, clinical trials USP Sterility,
Certificate of Process
Sterile Foil-Wrap Sterile processing is designed to destroy all living organisms. EP Scientific sterilizes glassware via a validated dry-heat, foil-wrap method. Stoppers and seals are sterilized via autoclave methods. Injectable or parenteral drugs, stability studies, clinical trials Certificate of Analysis – Endotoxins,
USP Sterility,
USP Particulates
USP Purified Water and WFI Rinses EP Scientific uses a state-of-the-art water purifi cation system which far exceeds the USP specifications for TOC, conductivity, bacterial, and endotoxin levels to provide a final product that meets FDA requirements. Various cleanroom applications in the pharmaceutical, biotech, medical, and semiconductor industries Certificate of Process
Steam
Sterilization		 The sterilization involves the application of steam, heat, and pressure to destroy all viable forms of life, including bacterial spores, to an acceptable sterility assurance level (SAL) of 10-6. Injectable or parenteral drugs, lyophilization, final packaging prior to drug delivery, stability studies, USP Sterility,
Certificate of Process

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