Spore Control In Pharmaceutical And Biotech Manufacturing Environments By STERIS Corporation
Drug manufacturing facilities are required to establish facility and process controls to prevent microbiological contamination (21 CFR 211.113). Bacterial endospores and fungal spores present significant contamination challenges in drug production areas, due to their prevalence in
the environment and inherent resistance to chemical inactivation.
Applying Good Engineering Practices To The Design Of Single-Use Systems By Martyn Botterill and Bruce Rawlings, Pall Life Sciences - BioPharmaceuticals
Significant changes are being
as a result of drivers such as
increasingly strict regulatory
demands, reduction of manufacturing
costs, and outsourcing to contract
manufacturing organizations (CMOs).
Datasheet: TESCOM PH-2200 Series TESCOM™ PH-2200 Series high-purity, single-stage regulator offers a compact, USP Class VI and BPE compliant design suitable for specialty, corrosive, and pyrophoric gases.
Brochure: Chemical Synthesis — Small Molecule API Manufacturing Using the latest chemical processes, including continuous flow technologies and microreactors, Lonza offers our exclusive synthesis of fine chemical intermediates, active pharmaceutical ingredients (APIs), highly potent APIs (HPAPIs,) and antibody drug conjugates (ADCs) under full cGMP for use in pharmaceutical products.
Brochure: Biosimilars/Follow-On Biologics Services ICON Clinical Research is a division of ICON PLC. It specializes in the planning, management, execution, and analysis of Phase IIb to IV clinical trials, ranging from small studies to complex, multinational projects.
Application Note: Cell Banking The cell bank is a critical element of the manufacturing process. Procedures for creating and subsequently using of cell bank repositories are well established, and have not changed significantly in years.