Small volume parenterals pdf

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In keeping with the editors' philosophy to update and adequately cover new subject matter, this second volume is now being published as part of a three-volume second edition of the series. Volume 1 in the second edition is devoted to parenteral drug history, administration, routes, precautions, problems, biopharmaceutics, preformulations, small and large volume parenteral formulations, peptide and protein injectables, sterile diagnostics, different types of parenteral primary packages and closures, and, finally, parenteral products in hospital and home care.

Volume 2 describes processing small and large volume parenterals, freeze drying, the design of a parenteral and a biopharmaceutical facility, personnel practices and training, environmental control elements in manufacturing, industrial sterilization, as well as an enlightening coverage of the therapeutics, types of drugs, and formulation principles for ophthalmic preparations.

The final and third volume in this series covers quality assurance, records and reports, particulate matter, validations, federal regulations, the audit process, regulatory considerations and other aspects of medical devices, including design, manufacture, and quality assurance. The editors have consistently guided the contributors to cover each subject with the intent of teaching at the level of the undergraduate, as well as the graduate student in the pharmaceutical sciences.

To accomplish this goal, the writers had to assume the readers to have little knowledge of the subject matter and then build upon the more basic concepts presented to reach the more learned and graduate level readers. Further, the materials presented in this series are intended to benefit the technical readers with the specific information required to guide professionals practicing industrial or pharmaceutical pharmacy, to assist personnel involved in the design and manufacture of sterile products, as well as to instruct lawyers and legislators concerned with all types of sterile products.

Also, new chapters have been added. Chapter 1 on the processing of small volume parenterals, has been expanded to include several types of biologic products, including biotechnology-based preparations such as vaccines and monoclonal antibodies. There is a discussion on preparing liposomal products, as well as a brief description concerning the manufacture of ophthalmic dosage forms. The use of form, fill, and seal equipment for small volume parenterals is described in detail with several diagrams and illustrations included to help provide additional clarity to this subject.

Many of the tables have been revised and the list of references updated. The chapter is designed to provide all the necessary details for setting up and running a state-of- the-art small volume parenteral facility.

In Chapter 2, the manufacturing processes describing large volume parenterals, has been considerably expanded compared with the presentation given in the first edition. Recent developments in the technology of parenteral fluid processing, the latest regulatory requirements, packaging including currently employed materials , filling, sterilization, and filtration operations, as all of them pertain to large volume parenterals, are fully covered.

In addition, the various factors involved in manufacturing large volume parenterals are reinforced by offering practical examples of situations and processes, both for improving production and quality assurance and control purposes. Chapter 3, "Freeze Drying: Principles and Practice," a new chapter in this edition, presents an overview of the scientific and engineering principles of freeze drying as it is relevant to the formulation and manufacture of freeze-dried parenteral products. Methodology for the characterization of freezing behavior is presented from the standpoint of identifying the maximum allowable product temperature during primary drying, that is, either a collapse temperature amorphous solute or a eutectic temperature crystalline solute.

Temperature and pressure measurement methods used in freeze drying are reviewed, followed by a discussion of process monitoring strategies. General equipment and considerations involved in designing a freeze drying system are discussed. Chapter 4 updates the various design considerations required for a parenteral production facility.

Specific reference has been included to small specialized batch operations where localized and self-contained sterile enclosures may be applicable, as for example, in the manufacture of lyophilized products. The HEPA filters topic has been updated and expanded in accordance with the current federal and Institute of Environmental Science standards. Laminar flow rooms with an illustration, separate gowning and degowning areas, various safety, environmental, hazardous material control, energy conservation, and building code issues have been reviewed and revised to reflect current pharmaceutical practices.

Chapter 5, which is new, describes the design of biopharmaceutical manufacturing facilities, concentrating on the physical layout, with particular consideration for the planning and regulatory issues that need to be addressed.

This chapter highlights the differences in planning for a biopharmaceutical manufacturing facility as compared with the design of aseptic facilities for parenteral products. No text concerned with the manufacture of sterile products would be complete without a description of "Personnel: The Key Factor in Clean Room Operations," Chapter 6 of this text.

The production personnel and the garments they wear when processing sterile preparations can play a significant role in the risk of contaminating these products in the manufacturing operations. To minimize this source of contamination, the chapter has provided a description of the concepts of barrier technology and a lengthy discussion on the design of clean room uniforms, fabrics currently prescribed, tests used to evaluate fabrics, and the effects of laundering on garment permeability.

Several types of face coverings worn by clean room operators are also described. Hand protection from microbial contamination and various hand washing techniques utilized by employees working in aseptic areas are discussed.

Overall contents of a training program for clean room operators, as well as a section on management philosophy and their commitment to regulatory compliance, are included in this chapter. Chapter 7, "Environmental Control in Parenteral Drug Manufacturing," has been rewritten to include more details regarding environmental monitoring, validation of airborne and surface contamination, and the implementation of a routine monitoring program.

This chapter discusses the hardware presently recommended for clean room construction and air filtration and also includes current regulatory requirements on these subjects.

New topics included in this chapter are cleaning, disinfection, and personnel cleanliness requirements needed to achieve adequate environmental conditions for an aseptic manufacturing facility. New concepts and principles relating to sterility assurance techniques and procedures have been added in this edition. Among the new subjects described are alternatives to ethylene oxide sterilization e.

Since ophthalmic preparations must be sterile, although not pyrogenfree, the editors have included in this series a new chapter, Chapter 9, "Development of Ophthalmic Formulations. In this chapter, topical ophthalmic products are discussed, andunlike many other pharmacy textsthe emphasis is on the development of intraocular preparations, particularly irrigating solutions.

It also includes a flow chart with model formulations for the development of ophthalmic preparations. Manufacturing procedures for the preparation and packaging of ophthalmic products are briefly described. No one author can offer the detailed and learned treatise required to adequately cover such a variety of subjects included in this volume.

The experts chosen in particular areas offer comprehensive knowledge at a level that will satisfy the requirements of both the novice and the highly experienced reader.

The contributing authors have worked hard to provide our readers with information needed to help them solve problems in manufacturing all types of sterile parenteral, biologic, and ophthalmic products. We are extremely grateful for the time and effort each has given to prepare a chapter despite a busy work schedule. We hope that the extensive coverage of the subject matter in this book will facilitate the reader's tasks, as well as elevate the present technology practiced in developing and manufacturing parenteral, biologic, and ophthalmic products.

Groves, Karen L. Malik, And Nicholas J. Kartinos 3. Nail And Larry A. Gatlin 4. Michael Keller And Gary L. Hoffman 5. Luna 7. Marino 9. Development of Ophthalmic Formulations Krishna M. Bapatla And 0. Membrane filter 0. It can block the blood vessel. Methods for monitoring particulate matter contamination: 1 Visual method 2 Coulter counter method 3 Filtration method 4 Light blockage method Optimization Techniques in Formulation and Processing.

In Encyclopedia of Pharmaceutical Technology. Rhodes, Marcel Dekker pg Thank You…….. Melissa Wilson Dec. No problem. NarendraKushwaha15 Sep. PatelAesha1 Jul. NeerajaGujarathi Jun. Show More. Total views. You just clipped your first slide! Clipping is a handy way to collect important slides you want to go back to later.

Now customize the name of a clipboard to store your clips. Visibility Others can see my Clipboard. Cancel Save. Exclusive 60 day trial to the world's largest digital library. Activate your free 60 day trial. Citrates, acetates etc. These include aqueous parenteral solutions e. After each heating, the resting period will allow spores that have survived to germinate into bacterial cells; these cells will be killed by the next day's heating.

If the temperature is increased then the time required for killing all the bacteria will be decreased. A minimum of C for not less than 1 hour. A minimum of C for not less than 2 hours. Ceramic filter Sintered glass filter RayShweta Dec. Anshuman Choudhary Dec.

Katrina Lewis Dec. Keerthana Dec. NeerajaGujarathi Jul. Show More. Total views. You just clipped your first slide! Clipping is a handy way to collect important slides you want to go back to later. Now customize the name of a clipboard to store your clips. General issues to consider for the design of process equipment: Process equipment has to meet the requirements of the product physical and chemical and process in terms of e.

Interface engineering is essential to avoid start up delays and additional costs Basis for the order should be a approved User Requirement Specification and a Technical Specification, nevertheless have regular visits at the equipment supplier and do a factory acceptance test before shipment to site Do not over design process equipment evaluate very clearly in the URS to specify the essential requirements I terms of GMP compliance features, performance features, material requirements etc.

The design of the equipment has to be user friendly, take attention to ergonomics, change over procedures already during the design phase, and consider this in the decision process for equipment selection. This is required for product contacting parts such as: - compounding vessel - filling machine - WFI; PW and clean steam system.

This is sufficient for secondary equipment such as: - inspection machines - packaging machines - Non product contacting surfaces e. Page The HVAC system together with the clean room has to secure: A GMP compliant environment in terms of particles, germs, air changes, airflow and separation of different clean room classes. Avoiding a contamination of the manufactured product e.

That the physical environmental requirements of the product will be met e. Prevention of any effects caused by the manufactured product to either personnel or environment or both e. That the staff is working in comfortable atmosphere. Mostly used in combination with above systems, e. LF Page Process utilities: Fluids, steam or gasses which are: - part of the product itself or - directly in contact with the product or - used to clean surfaces in the clean room, or for equipment cleaning Fluids: - Purified water PW - Highly purified water HPW - Water for Injection WFI - Solvents Gasses: - Compressed air - Nitrogen, Oxygen - Other gasses e.

Carbon dioxide etc. Steam: - Clean steam Page Purified water: EP European Pharmacopea : Purified Water is intended for use of manufacturing preparations that do not have to be sterile or pyrogen free, unless otherwise explained and authorised USP United States Pharmacopea : Purified Water is intended for use as an ingredient of official preparations and in tests and assays unless otherwise specified Highly purified water: EP European Pharmacopea : Highly purified water is intended for preparation of pharmaceuticals that need water of a high biological quality, except where water for injection is necessary e.

GMP requirements for monitoring and recording Where possible sensors for control and recording should be independent e. All sensors to be considered as GMP critical have to be calibrated on a regular basis The right approach to evaluate which sensor is GMP critical is normally done within the risk analysis process GMP risk analysis. Example: Paperless recorder Comes with full CFR part 11 compliance, can be connected via Ethernet to a central computer or via flash card, also GMP relevant text strings can be printed, no limitation in terms of printers to be connected to the PC.

Internal memory stores results before data transfer is successfully completed. Qualification Action of proving that any equipment works correctly and actually leads to the expected results. The word validation is sometimes widened to incorporate the concept of qualification. Any aspect of, including significant changes to, the premises, the facilities, the equipment or the processes, which may affect the quality of the product, directly or indirectly, should be validated and qualified.

Qualification provides documented evidence that equipment is designed and works as it should: Qualification equipment-related. Validation provides documented evidence that processes lead to product of the desired quality and safety: Validation process-related Page This normally constitutes Design Qualification or DQ.

This constitutes Installation Qualification or IQ.