The pharmaceutical vial capping process: container closure systems, capping equipment, regulatory framework, and seal quality tests

R Mathaes, HC Mahler, JP Buettiker, H Roehl… - European Journal of …, 2016 - Elsevier
Parenteral drug products are protected by appropriate primary packaging to protect against
environmental factors, including potential microbial contamination during shelf life duration …

Freeze drying of biologics

BS Bhatnagar, S Tchessalov… - Encyclopedia of …, 2013 - api.taylorfrancis.com
The development and commercialization of small molecules has been the traditional focus
of the pharmaceutical industry. However, since the advent of recombinant DNA technology …

Container and Reconstitution Systems for Lyophilized Drug Products

TP McAndrew, D Hostetler, FL DeGrazio - … of Pharmaceuticals and …, 2019 - Springer
Lyophilization is the process of dehydrating a material at low temperature and reduced
pressure. It is used to extend the shelf life of many biologic drug products. This paper …

Use of leftovers of monoclonal antibody products after partial extraction–A microbiological safety study

AH Arnamo, ADR Huitema… - Journal of Oncology …, 2020 - journals.sagepub.com
Background/purpose In the absence of thorough microbiological, chemical and physical
stability data, high amounts of pharmaceutical products, from which the seal has been …

Parenteral container closure systems

R Mathaes, A Streubel - Challenges in Protein Product Development, 2018 - Springer
Parenteral container closure systems are in direct contact with the drug product formulation
and can significantly impact the product quality. The interaction between the drug product …

Primary Container Closure System Selection for Lyophilized Drug Products

R Ovadia, P Lam, H Roehl, R Janssen… - Principles and Practices …, 2023 - Springer
For lyophilization applications, the selection of the primary container system (ie vial, stopper,
seal) must be given careful consideration in order to avoid surprises in the later stages of …

[PDF][PDF] A REVIEW ON ADVANCED PARENTERAL DRUG DELIVERY AND MANUFACTURING TECHNOLOGY

P Aneja, R Guleria, S Garad, S Aneja, Y Thakur… - 2024 - wjpr.s3.ap-south-1.amazonaws.com
Parenteral drug delivery refers to the administration of pharmaceuticals directly into the body
through non-oral routes, bypassing the gastrointestinal tract. It offers several advantages …

A review on freeze-drying: A stability enhancement technique

I Silambarasan, AN Rajalakshmi - Research Journal of …, 2022 - indianjournals.com
Freeze-drying is effective technique used in pharmaceutical industry to increase the efficacy,
shelf-life of formulations and makes easier to transport and storage. Freeze-drying applies to …

Recent trends in lyophilized delivery devices and packaging

R Janssen - Lyophilized Biologics and Vaccines: Modality-Based …, 2015 - Springer
A description is given of the primary and secondary packaging components for lyophilized
products. A discussion is presented on the geometry and design features of elastomeric …