Vial filling and terminal sterilisation for drug in pharmacology FDA Essay

Vial filling and terminal sterilisation for drug in pharmacology FDA - Essay Example The main sterilization processes relate to terminal sterilization and aseptic filing process which incorporates the vial filling and syringe filling. The Closed Vial Filling System (CVFS) is composed of containers that are sterile and closed and are filled through their stoppers, then resealed again immediately to avoid entry of bacteria. The main characteristics of the process relate to a surrounding environment of ISO 8 minimum operation, an enclosure system, sanitization and prevention of material entry. The enclosure system includes a rig was to separate the operation from operators, HEPA-filtered air flow supplied from the ceiling with air exit, locked doors, with alarms, glove ports for area access entry of product to be filled and through aseptic connector. The entry of material is through closed vials that have been pre-sterilized by gamma rays, through rapid transfer ports (RTP) and through VHP airlock using PE wrapped vial. Entry can also be through caps which are sterilized earlier and a fluid path sterilized by gamma rays. Sanitation is through disinfection of all contact places, bags for fluid path and within the vials using an agent with spores. High quality and design are observed in the terminal sterilization

International Negotiations (Lansa and Newco Case) Essay

International Negotiations (Lansa and Newco Case) - Essay Example The government partially regulates Lansa (Brett 33). The Argentine Ministro de Industria Tecnologica serves on the Board of Directors. Lansa’s headquarters is in the outskirts of Buenos Aires; however, all the manufacturing and distribution comes out of Mexico. Newco’s CEO, Mr. Abercrombie, has the mandate to expand into South America with a new product line called â€Å"infomatrix†. Infomatrix is a remarkable telemetry unit that facilitates voice and data communication between all types of vehicles such as automobiles, boats, helicopters. Since Newco had previously approached Lansa at an international Telecommunication convention in London, Newco’s CEO decides to try again. On the other hand, Lansa is doing well. The CEO, Mr. Lopez, has also heard about infomatrix. He decides to approach Newco having seen that a joint venture can further boost the success of his company (Rubin 14). Objectives Newco’s objective aims at raising the value of the stock . Their main concern is to get a written document that would permit public disclosure. Lansa’s concern is dealing with an American company. It believes it has something to offer and its willingness to carry what it can understanding (Rubin 45). Lansa would also like to have a document in writing that would permit public disclosure. Mr. Arricoitxea thinks of securing an office in the upcoming elections and the company’s success would be a significant boost during his campaign. Both Newco and Lansa are aiming at taking advantage of NAFTA. Considerations Mr. Abercrombie sends a five man advanced team to Mexico upon request from Mr. Lopez. The negotiation advanced team comprises a representative of the corporate managers who is the lead negotiator, a corporate lawyer, a market analyst, a telecommunication engineer and a representative of the corporate shareholders. The representative of corporate managers brings in and supports the ideas and proposals of the corporate mana gers. By representing the interests of the corporate managers, he is in the best position to lead the negotiating team (Rubin 56). The corporate lawyer will ensure that all the transactions made are legally binding within the law. His knowledge in corporate law will be a key factor to be used during the negotiations. The market analyst can assess the viability of the market for the product. He analyzes the market price and other economic aspects that will help determine if the product will succeed in the proposed market. He will be able to convince the Lansa Company that the product will succeed in their market (Thomson 77). The telecommunication engineer becomes equipped to give any details with regards to the infomatrix. His knowledge of the product will be extremely useful in negotiating for the importance of infomatrix in the market. The representative of the shareholders will be able to back the other negotiators in his team during negotiations since he is representing the inte rests of the corporate shareholders. The main players in the international negotiations are Newco and Lansa. Newco has a new product, â€Å"infomatrix† that could enable them to expand to the South American market and hence further increase its profitability in the future. Lansa believes that a joint venture with Newco could further boost its success in