Pharmaceutical Manufacturing Formulations
Six Volume Handbook from C.H.I.P.S.

Volume 1
Compressed Solid Products
Volume 2
Uncompressed Drug Products
Volume 3
Liquid Products
Volume 4
Semi-Solid Products
Volume 5
Over the Counter Products
Volume 6
Sterile Products
Complete Six Volume Set

Handbook of Pharmaceutical Manufacturing Formulations
Volume Six
Sterile Products

Second edition
edited by Sarfaraz K. Niazi

No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing sterile products has evolved into a very sophisticated industry.

Highlights from Sterile Products, Volume Six include:

  • formulations of sterile dosage forms, regulatory filing requirements of sterile preparations, and cGMP compliance, all of which are tied together in the final preparation of the CMC sections of regulatory applications
  • specifications of a manufacturing facility to manufacture compliant sterile products
  • NDA or aNDA filing requirements of sterile products
  • an alphabetical presentation of formulations of pharmaceutical products based on their generic names


Section I: Sterile Manufacturing Practice

Chapter 1: Inspection of Sterile Product Manufacturing Facilities

  • cGMP Compliance Basics
  • Aseptic Processing
  • Processing Prior to Filling and Sealing Operations
  • Aseptic Processing Isolators
  • Blow-Fill-Seal Technology
  • Lyophilization of Parenterals
  • High-Purity Water Systems

Chapter 2: New Drug Application for Sterilized Products

  • Terminal Heat Sterilization
  • Other Terminal Sterilization Processes
  • Aseptic Fill Manufacturing
  • Maintenance of Microbiological Control and Quality: Stability Considerations

Chapter 3: Manufacturing Formulations Template

  • Autoclaves
  • Aseptic Contract Manufacturers
  • Clean Room Design and Construction
  • Clean-in-Place/Steam-in-Place (CIPISIP)
  • Closure Washing and Sterilization
  • Consultants
  • Disinfectants and Preservatives
  • Distillation Equipment
  • Engineering and Construction
  • Filling Machines
  • Filter Aids
  • Flowmeters (Sanitary)
  • Freeze-Dryers (Sterilizable)
  • Microfiltration Equipment and Filters
  • Pumps (Sanitary)
  • Sterile Tanks and Related Stainless Equipment
  • Sterility Test Equipment
  • Sterilizing and Drying Tunnels (Hot Air)
  • Stoppering Machines
  • Vial and Bottle Washers

Section II: Sterile Pharmaceutical Formulations

Contains more than 400 formulations. Partial list follows:

  • Abciximab Injection
  • Acetazolamide Injection
  • Acetylcholine Chloride Intraocular Solution
  • Acyclovir Sodium Injection
  • Adenosine Injection
  • Adrenal Cortex Injection
  • Adrenaline Tartarate Injection
  • Alatrofloxacin Mesylate Injection
  • Albumin (Human)
  • Albuterol Sulfate Inhalation Solution
  • Aldesleukin for Injection
  • Alemtuzumab Injection
  • Alpha Tocopherol (Vitamin E) Injection
  • Alprostadil for Injection
  • Alteplase Recombinant Injection
  • Amikacin Sulfate Injection
  • Amino Acid Parenteral Nutrition Solution
  • Aminohippurate Sodium for Injection
  • Aminophylline Injection
  • Amiodarone Injection
  • Amoxicillin–Clavulanic Acid Injection
  • Amoxicillin Powder for Injection
  • Amphotericin B Cholesteryl Sulfate Complex for Injection
  • Amphotericin B Injection
  • Amphotericin B Lipid Complex Injection
  • Amphotericin B Liposome for Injection
  • Antazoline Sulfate and Xylometazoline Hydrochloride Ophthalmic Drops
  • Antipyrine, Phenylephrine, and Pyrilamine Maleate Ophthalmic Drops
  • Antipyrine, Phenylephrine, and Sodium Thiosulfate Ophthalmic Solution
  • Antithymocyte Globulin (Rabbit) for Injection
  • Aprotinin Injection
  • Argatroban (Thrombin Inhibitor) Injection
  • Arsenic Trioxide Injection
  • Ascorbic Acid and B-Complex Vitamins
  • Ascorbic Acid, B-Complex Vitamin, with Beta Carotene Injection
  • Ascorbic Acid Injection
  • Ascorbic Acid, USP, Injection
  • Ascorbic Acid, USP, 250 mg/mL Injection
  • Asparaginase for Injection
  • Atropine, Chlorpheniramine Maleate, and Phenylpropanolamine Injection
  • Atropine Sulfate Injection
  • Aztreonam for Injection
  • Basiliximab for Injection
  • B-Complex Injection
  • B-Complex, Vitamin D, Vitamin E Lyophilized Injection
  • B-Complex Vitamin Veterinary
  • B-Complex with Minerals Injection (Veterinary)
  • B-Complex Vitamins with Hormones
  • B-Complex Vitamins with Liver Extract Injection
  • Benzodiazepine Injection
  • Benztropine Mesylate Injection
  • Beta-Carotene Injection
  • Betamethasone Suspension Injection
  • Bethanechol Chloride Injection
  • Biotin Injection
  • Biperiden Lactate Injection
  • Bisantrene Emulsion Injection
  • Borax Sodium Lubricating Ophthalmic Drops
  • Botulinum Toxin
  • Bretylium Tosylate in Dextrose Injection
  • Buflomedil Injection
  • Bupivacaine Hydrochloride Injection
  • Buprenorphine Hydrochloride Injectable
  • Caffeine Citrate Injection
  • Calcitonin Injection
  • Calcitriol Injection
  • Calcium Glycerophosphate Injection
  • Calcium Injection
  • Camphor Injection
  • Camptothecin Injection
  • Carboplatin for Infusion
  • Carboplatin Injection
  • Carprofen Injection
  • Cefamandole Nafate for Injection
  • Cefazolin Injection
  • Cefepime Hydrochloride for Injection
  • Cefotaxime Injection
  • Cefotetan Injection
  • Cefoxitin Injection Premixed Intravenous Solution
  • Ceftazidime for Injection — L-Arginine Formulation
  • Ceftazidime Injection
  • Cefuroxime for Injection
  • Cetrorelix Acetate for Injection
  • Chloramphenicol and Phenylmercuric Nitrate Ophthalmic Drops
  • Chloramphenicol for Injection
  • Chloramphenicol Injection
  • Chloramphenicol Sodium Succinate for Injection
  • Chlordiazepoxide Hydrochloride Injection
  • Chloroprocaine Hydrochloride Injection
  • Chloroquine Phosphate Injection
  • Chlorothiazide Sodium for Injection
  • Chlorpheniramine Maleate Injection
  • Chlorpromazine Hydrochloride Injection
  • Choriogonadotropin Alfa (Recombinant) for Injection
  • Chorionic Gonadotropin for Injection
  • Chromium Chloride Additive Injection
  • Cidofovir Injection
  • Cimetidine Injection
  • Ciprofloxacin Hydrochloride Ophthalmic Solution
  • Ciprofloxacin Injection
  • Cisplatin Diaminedichloride Injection
  • Cisplatin with 2,2¢-Dithio-bis-Ethane Sulfonate Injection
  • Cladribine Injection Infusion
  • Clarithromycin Injection
  • Clindamycin Injection in 5% Dextrose
  • Clindamycin Phosphate Injection
  • Clonidine Hydrochloride Injection
  • Coagulation Factor VIIa (Recombinant) for Injection
  • Coagulation Factor IX (Recombinant) for Injection
  • Colistin Sulfate, Neomycin Sulfate, Thonzonium Bromide, and Hydrocortisone Acetate Otic Suspension
  • Conjugated Estrogens for Injection
  • Copper Sulfate Additive Injection
  • Corticorelin Ovine Triflutate for Injection
  • Cortisone Acetate Injectable Suspension
  • Cosyntropin for Injection
  • Cromolyn Sodium Ophthalmic Solution
  • Crude Liver Extract Injection
  • Cyanocobalamin and Thiamine Injection
  • Cyanocobalamin, Choline, and Niacinamide Injection
  • Cyanocobalamin Injection
  • Cyanocobalamin Injection for Veterinary Use
  • Cyanocobalamin Repository Injection 1000 mg/mL
  • Cyanocobalamin, Pyridoxine, and Thiamine Injection
  • Cyclosporine Ampoules for Infusion
  • Cytarabine Liposome Injection for Intrathecal Use, 50 mg/5 mL Vial
  • Cytomegalovirus Immune Globulin Intravenous (Human)


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Handbook of Pharmaceutical Manufacturing Formulations
Volume Six: Sterile Products • Second edition
2009 • 488 pages • $389.95 + shipping

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Handbook of Pharmaceutical Manufacturing Formulations
Complete Six Volume Set • Second edition

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