Steriles
There are inherent expectations of patients, health-care providers, and regulatory agencies for effective and safe injection drug products. This expectation requires that the quality, purity and quality of injected drugs be met. Unqualified injection products may result from inappropriate production processes, including the inadvertent use of inferior or incorrect APIs or excipients; manufacturing processes that pollute or adequately ensure asepsis; and packaging designs or inadequate quality. Ineffective quality control measures, whether sponsored by manufacturers or customers, may allow these defects not to be detected.
Our Services
With more than 20 years of experience in the commercial production of aseptic injections, we provide a wide range of aseptic drug development and manufacturing capabilities on all scales, including liquid filling and freeze-dried vials. We also provide state-of-the-art commercial cGMP manufacturing for pre-loaded syringes and syringes. One-time (one-time) manufacturing technology and traditional stainless steel equipment available
- Unique technology and aseptic filling experience are combined with cGMP’s extensible aseptic filling/completion kit to support clinical production through commercial production.
- Can accommodate ISO and non-ISO vials.
- Develop scale manufacturing capabilities suitable for the manufacture of clinical trial materials.
- One-time (one-time system) manufacturing solutions are available.
- There are many kinds of products, including large molecules and small molecules.
- In-house technical expertise and advanced microbiology and chemistry laboratories to provide services for incoming, in-process and finished product testing capabilities.
- Verification, transfer and stability research procedures for analytical methods in accordance with ICH criteria.
- Superior quality and regulatory compliance of multiple regulators around the world.
- New features are constantly being added. A detailed list of current features can be provided upon request.
Why Choose BOC Sciences?
Whatever your manufacturing requirements are, BOC Sciences will provide more to meet your expectations. Our aseptic capabilities also include process development and manufacture of biopharmaceuticals on a global commercial scale, from clinical to global commercial scale. With BOC Science as your single-source partner, you will be able to bring your findings to market with unprecedented speed and efficiency.