Sterile Liquid Injectables: Aseptic fill on a state-of-the-art fill / finish crimp-cap line, capable of aseptic filling 1 – 125 ml vials with extremely low dead volume. We have validated methods in place for sterile filling 2, 3, 5, and 20 ml vials up to 30,000 units per run.
Sterile Syringe Fill: Our Accofil LM14 semi-automated powder filling machine are used for aseptic filling of oligos, peptides and small molecules.
Supporting our process equipment are validated services including a USP water system, pure steam generator, autoclave and depyrogenation oven. Validation capabilities include, but are not limited to, media aseptic fill simulation studies, terminal sterilization loads, autoclave equipment loads, depyrogenation oven loads, container closure integrity and process validation. Dalton also has the ability to develop or transfer technology related to aseptic processing. In addition, Dalton’s analytical chemistry laboratory offers method development, validation and ICH stability programs to its clients. QC/QA, Microbiology and Regulatory Affairs Departments support all analytical data.
We are currently manufacturing sterile medical devices and commercial products under GMP. We have manufactured many products for clinical trials (Phase I, II and III).
In a regulated industry, special care must be taken to ensure all equipment and processes are performing to specifications. Deviations can have unpredictable and sometimes devastating results. Therefore, we pay special attention to equipment qualification and process validation to provide full regulatory compliance for its clients. We follow the strictest guidelines, perform the most rigorous testing and execute studies in a timely fashion to ensure your product is of the highest quality when it reaches its destination.
Dalton has capabilities to develop, create and execute validation protocols and studies required for your products and equipment in accordance with current Guidelines (HPFBI, FDA, EP, ICH, WHO) and acceptable formats (prospective, retrospective and concurrent). These include process, cleaning, aseptic processing, terminal sterilization, environmental control, IQ/OQ/PQ/PV and utility qualifications. Statistical and decision making analysis is also part of our service.
We stand by our products, which are manufactured to the highest quality standards. Learn more about our Custom Drug Synthesis Products.
If what you are looking for is not on the list please contact us at 1-800-567-5060 or 416-661-2102 or email us and we will gladly meet your requirements for GMP Aseptic Filling of Oligonucleotides.