GMP Sterile Filling – Drug Filling Facility

Our GMP Sterile Filling capabilities will support your drug development process as it advances through clinical trials. Our pharmaceutical manufacturing facility confirms Dalton’s flexibility by handling both aseptic liquid and powder fill into sterile vials or syringes. Formulation can be done in-house or by the customer.

The Drug Filling contract manufacturing area maintains a static and operational Grade A (ISO Class 5) environment. All areas of the our Sterile Filling contract manufacturing facility, including ancillary support areas, are routinely monitored for viable airborne contamination, viable

contamination on surfaces and non-viable airborne contamination by our QC Microbiology Laboratory. The area is also supported by our Analytical Chemistry Laboratory and Quality Assurance Department.

Dalton offers fully integrated GMP Class 100 Sterile Filling and capping of liquid in-vial injectable drugs, liquid pre-filled and stoppered syringes and powder filling / capping for preclinical and early stage clinical trials:

Sterile Liquid Injectables: machine fill on a state-of-the-art fill / finish crimp-cap line, capable of Sterile Filling 1 – 125 ml vials with extremely low dead volume. We have validated methods in place for Sterile Filling 3, 5, and 20 ml vials up to 20,000 units per run and are currently in the process of validating a method for 2 ml vials.
Sterile Powder Fill: using our Accofil LM14 semi-automated powder filling machines to sterile fill oligos, peptides and small molecules. We currently have a validated process to fill 1800 units in 20mL vials.
Sterile Syringe Fill: we have capability of filling 2, 3, 5, 10 and 20 ml syringes, and validated method for filling 2ml syringes up to 20,000 / batch.

The production of sterile pre-filled syringes is on a Cozzoli F329HE-10-SS Sterile Filling machine that can handle various aqueous solutions and creams with 10x10, 8x8, 6x7 and 5x6 syringe formats and production of 5,000 - 7500 units/ hour.

Our commitment to the customer is demonstrated by the fact that we welcome small scale fills that may not meet the minimum number of vials requirement of other sterile fill companies.

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 sterile 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.

Dalton is in the planning stages of expanding it's capabilities in the sterile fill / finish and has purchased a new Sterile Filling line that will allow us to fill up to 100,000 units per batch. In addition, we are expanding our lyophylization capabilities and anticipate that we will also offer this service to our clients in the near future.

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).

Validation
In a regulated industry, special care must be taken to ensure all equipment and processes are performing to specifications. Deviations from the norm could have unpredictable and sometimes devastating results. Therefore, Dalton pays special attention to equipment qualification and process validation to provide full regulatory compliance to 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 and terminal sterilization processes, 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. Click here to view our product list.

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 GMP Sterile Filling needs.