Organichem Corporation offers a wide range of third-party development and manufacturing capabilities to chemical and pharmaceutical companies. It is a world leader in contract manufacturing of bulk active pharmaceutical ingredients. Products manufactured by Organichem include controlled substances, cancer-fighting drugs, and diagnostic imaging agents.
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This strategy guide, written in a make-you-think cliff notes style, includes multiple questions that need to be thought through and answered and activities that need to be performed, by internal staff or external resources. Also listed are various bullet pointed benefits that everyone proclaims from serialization to derive ROI and business value. While others talk about value in the ether, our engagements include actionable business value opportunities in our deliverables .
These days several Pharmaceutical companies are moving to single use, flexible film isolators for containment of potent compounds during Pharmaceutical processing. Flexible film isolators have also been used for aseptic processes, like sterility testing. These isolators are a low cost, simple design generally consisting of a stainless steel lower framework which supports a work table and an upper stainless steel framework that supports the flexible enclosure. Typical enclosure material can be polyvinylchloride or polyurethane. The glove sleeves are often made of the same materials and are part of the enclosure. Air passes through inlet and outlet filters. Blowers can be included to create positive or negative air pressure and ports or panels added for introducing or removing items to or from the isolator. These isolators are lightweight, easy to set up, have good visibility and good flexibility while working in the gloves.
Lyophilization is a complex process that presents many manufacturing challenges, one of which is maintaining and monitoring container closure integrity of the finished package. Container closure integrity plays an important role in maintaining the sterility and stability of lyophilized products. Concerns over patient safety, customer complaints, and the cost of investigations and product recalls have recently resulted in revised regulatory guidance (e.g. the revised Annex 1 of the European Guidelines for the Manufacture of Sterile Products).
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Ophthalmic products come in a variety of package formats and have a variety of eye-care applications. The liquid filled package formats are often soft containers with snap on or torque screw caps, but also include foil lidded blister packs for single use contacts. Most contact lens solutions clean, disinfect, lubricate, and remove protein deposits from the lens while matching certain chemical properties of the ocular area. While these solutions may disinfect, similar properties to ocular fluids and increasing resilience of new bacterial and fungal strains make contamination a greater concern. Any breach, channel, or micro leak in the container closure greatly increases the risk of contamination of the ophthalmic solution.
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The objective of this white paper is to provide background to assist those functions involved in implementing serialization methodologies for pharmaceutical products. Because the topic is extremely broad in nature, this paper will focus specifically on how checkweighers can play a significant role in addressing track and trace requirements for package components.
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A Guide To Pharmaceutical Serialization: Choosing The Right Equipment Supplier
A major pharmaceutical company used a very highly customized Documentum WDK Application for content authoring and submission management.
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