Seems you have not registered as a member of brazil123.net!

You may have to register before you can download all our books and magazines, click the sign up button below to create a free account.

Sign up

Pda Technical Report 26, Sterilizing Filtration of Liquids #01026
  • Language: en
PDA Technical Report No. 39 (Revised 2007)
  • Language: en

PDA Technical Report No. 39 (Revised 2007)

  • Author(s): PDA
  • Type: Book
  • -
  • Published: 2007
  • -
  • Publisher: Unknown

None

PDA Technical Report No. 28 (Revised 2006)
  • Language: en

PDA Technical Report No. 28 (Revised 2006)

  • Author(s): PDA
  • Type: Book
  • -
  • Published: 2006
  • -
  • Publisher: Unknown

None

PDA TECHNICAL REPORT NO. 53 (TR 53) GUIDANCE FOR INDUSTRY
  • Language: en

PDA TECHNICAL REPORT NO. 53 (TR 53) GUIDANCE FOR INDUSTRY

  • Type: Book
  • -
  • Published: 2011
  • -
  • Publisher: Unknown

None

The Computer System Risk Management and Validation Life Cycle
  • Language: en
  • Pages: 576
Sterilisation of Polymer Healthcare Products
  • Language: en
  • Pages: 326

Sterilisation of Polymer Healthcare Products

Sterilisation has always been challenging but sterilisation of healthcare products and polymers, especially together is an even greater challenge - how do you sterilise without adversely affecting the end use or the end user? This book discusses all the sterilisation methods used for polymeric healthcare products both traditional and new.

Advanced Aseptic Processing Technology
  • Language: en
  • Pages: 496

Advanced Aseptic Processing Technology

  • Type: Book
  • -
  • Published: 2016-04-19
  • -
  • Publisher: CRC Press

The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies for aseptic processing that will markedly reduce the level of contamination risk for sterile products and includes coverage on: The use of isolator and barrier concepts for aseptic processing and assembly. The application of robotics as an alternative to gowned personnel. The increasing reliance on automation to minimize or eliminate operator inter...

Sterile Product Development
  • Language: en
  • Pages: 585

Sterile Product Development

This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to ...

Good Quality Practice (GQP) in Pharmaceutical Manufacturing: A Handbook
  • Language: en
  • Pages: 460

Good Quality Practice (GQP) in Pharmaceutical Manufacturing: A Handbook

Pharmaceutical manufacturing can be viewed as a supply chain which spans from the production and purchase of the starting and packaging materials through the manufacture of dosage forms until the safe reception of the finished product by the patient. The entire chain comprises of several processes: auditing, materials purchase (procurement), production, storage, distribution, quality control, and quality assurance. The quality standard for pharmaceutical production is ‘current good manufacturing practice (CGMP)’‘, which is applied within the frame of a pharmaceutical quality system (PQS). This implementation, however, requires a scientific approach and has to take into account several ...