Our analytical testing labs are furnished with appropriate equipment such as safety workbenches for sample preparations, containment hoods and isolators for testing samples, and separation from the normal lab areas and with limited access. Stason complies with all applicable laws with respect to the environment, occupational health and safety, public health & safety, waste disposal, and holds all current and applicable governmental licenses, approvals, permits & authorizations.
Stason currently references the SafeBridge® categorization scheme and works with SafeBridge® Category 1-4 compounds. The SafeBridge “Occupational Health Toxicity/Potency Categorization and Handling Practices” system (copyright SafeBridge Consultants, Inc., Fifth Revision – January 2002, pp.12), is a four-category system to characterize compound potency.
Dosage Form Capabilities
Stason also operates a dedicated High Containment facility, which is segregated from our Non-High Containment operations, and consists of multiple processing suites, a dedicated packaging room, a documentation room, and field support offices. The air handling system provides a minimum of 40 changes of filtered air per hour.
In addition to our solid dosage manufacturing capabilities (tablets & capsules), Stason offers injectable & liquid manufacturing through our partnership with Standard Chem. & Pharm. Co. Ltd. in Tainan, Taiwan. The Taiwan GMP facility located at Campus2, accommodates both liquids and ointments. The GMP facility on Campus1, is devoted to injectables and offers: lyophilization, suspension, powder filling, and liquids. For more information regarding our manufacturing partnerships in Taiwan, please inquire with us, firstname.lastname@example.org.
Clinical Supply & Commercial Pharmaceutical Manufacturing
- Bench-Top (0.5 – 1 kg)
- Pilot (3-5 Kg)
- Commercial (50-600 kg)
QC Testing & Stability Monitoring for Commercial Manufacturing
Stability storage conditions meet ICH guidelines. Each cGMP environmental chamber operates independently, with separate temperature controls, and monitored continuously through a validated environmental monitoring system. All storage chambers are supported by full generator back-up, in case of power failure.
ICH Stability Chambers:
- Customized Conditions (for example: Zone IV).
Stason performs release & stability testing for small molecule drugs (brand, generic) and diagnostic products. Appropriate sampling and testing methods are determined, documented and executed. Analytical services supporting stability programs include: long-term stability testing, accelerated stability testing, comparative stability testing, and forced degradation studies.
Pharmaceutical Packaging: Solid, Semi-Solid & Sterile Dosage Forms
Our capacity includes:
- Multiple automatic encapsulation machines with capacity of 50,000 capsules per hour. Capable of filling powder, granules, pellets, and minitablets from Size 00 to 04
- Automatic packaging line with capacity of up to 100 bottles/minute
- Induction Cap sealing machine
- Unit dose blister packaging line
Our global integrated network of affiliates and distribution sites allows us to package and distribute supplies worldwide. Multiple automatic and semi-automated packaging lines are used for clinical and commercial packaging processes. Manual packaging is available for custom configurations. Our global distribution network adheres to the strict rules and regulations necessary for global transfer.