Sterile Pharmaceutical Products

Parenteral drug delivery systems and many medicinal products, such as dressings and sutures, must be sterile to avoid the possibilities of microbial degradation or infection occurring as a result of their use.

Sterility is also important for any material or instrument likely to contact broken skin or internal organs. Although pathogenic bacteria, fungi or viruses pose the most obvious danger to a patient, it should be also realized that microorganisms usually regarded as non-pathogenic and which inadvertently gain access to body cavities in sufficient numbers may cause a severe, possibly fatal infection.

Consequently, injections, ophthalmic preparations, irrigation fluids, dialysis solutions, sutures and ligatures, implants, certain surgical dressings, as well as instruments necessary for their use or administration, must be presented in a sterile condition. Whilst there is always a chance of an idiosyncratic reaction between a medicine and a patient caused by sensitivity, allergic reaction or unwanted sideeffects, for sterile products there is the added requirement that they must be free of viable microorganisms. This consequently means the product should be manufactured in a manner that reduces to the lowest likelihood the risk of microbial contamination. Thus a sterile product should not contain viable bacteria, yeasts or fungi, nor other microorganisms such as rickettsiae, mycoplasmas or protozoa and viruses. The absence of prion particles is also desirable but difficult to demonstrate. Sterilization processes concentrate on the destruction or removal of microorganisms. Each process is designed to remove the most problematic microorganism (i.e. the smallest bacteria in filtration or the most heat resistant bacterial spores in heat sterilization processes) on the basis that, once a sterilization process has been chosen, elimination of the most problematic species will have led to the elimination of all less resistant microorganisms.

The choice of method is determined largely by the ability of the formulation and container to withstand the physical stresses applied during the sterilization process. All products intended for sterilization should be manufactured under clean conditions and therefore will be of low microbial content (bioburden) prior to sterilization. Under these conditions, the sterilization process will not be overtaxed and will generally be within the safety limits needed to provide the required level of sterility assurance. The next section emphasizes parenteral products, but the practices described apply to many other types of sterile product.

  • Novel Approaches in Biopharmaceutics
  • Drug Discovery & Development

Related Conference of Sterile Pharmaceutical Products

May 29-31, 2017

International Conference On Microbial Engineering

Beijing, China

11th World Congress on Virology

Vancouver, Canada
July 31-Aug 02, 2017

The Virology Congress

Melbourne, Australia
(10 Plenary Forums 3 days 1 Event)
August 28-30, 2017

2nd International Conference and Expo on Water Microbiology & Novel Technologies

Philadelphia, Pennsylvania, USA
August 31-September 1, 2017

6th International Conference on Microbial Physiology and Genomics

Brussels, Belgium
Aug 31- Sep 1, 2017

International Conference on Chronic Diseases

Brussels, Belgium
(8 Plenary Forums 2 days 1 Event) September 13-14, 2017

2nd International Conference on Infectious Diseases & Diagnostic Microbiology

Dallas, Texas, USA
September 18-19, 2017

46th World Congress on Microbiology

Dublin, Ireland
September 18-20, 2017

International Conference on Microbial Ecology & Eco Systems

Toronto, Ontario, Canada
(10 Plenary Forums 3 days 1 event)
Sep 18-19, 2017

2ndInternational Conference on Medical Parasitology

Zurich, Switzerland
(10 Plenary Forums 2 Days 1 Event)
September 18-19, 2017

International Conference and Expo on Medical Virology & Infectious Diseases

Houston, Texas, USA
(10 Plenary Forums 3 Days 1 Event)
September 18-20 , 2017

6th International conference on Environmental Microbiology & Soil Microbiology

Toronto, Canada
September 18-20, 2017

4thGlobal Applied Microbiology Summit

San Antonio,Texas, USA
(8 Plenary Forums 2 days 1 Event)
September 25-26, 2017

2nd International Conference on Mycology & Mushrooms

Chicago, Illinois, USA
(8 Plenary forums, 2 days, 1 event)
September 25-26, 2017

7th Annual Congress on Clinical Microbiology

Chicago, Illinois, USA
October 02-03, 2017

3rd International Congress on Microbiology

Atlanta, Georgia, USA
(10 Plenary Forums 3 days 1 Event)
October 2-4, 2017

2ndGlobal Medical Microbiology Summit & Expo

Las Vegas, USA
(10 Plenary Forums 3 Days 1 Event )
October 02-04, 2017

International Congress on Nosocomial and Healthcare Associated Infections

Las Vegas,Nevada,USA
October 16-17, 2017

12th World Congress on Virology

Baltimore, Maryland, USA
October 16-18, 2017

Annual Meeting on Viral Outbreaks and Epidemiology

Baltimore, USA
(10 Plenary Forums 3 days 1 Event)
October 16-18, 2017

Annual Conference on Microbes and Beneficial Microbes

Baltimore, Maryland, USA
March 13-14, 2017

9th International Virology Congress and Expo

London, UK
October 26-28, 2017

8th Clinical Microbiology Conference

Paris, France
(9 Plenary forums, 3 days, 1 event) Oct 30-Nov 1,

4th World Microbiologists Annual Conference

San Antonio, USA
November 06-08, 2017

Microbiology- 2017 (CME & CPD Accredited)

Valencia, Spain
(10 Plenary Forums 2 days 1 Event)
November 13-14, 2017

2nd International Congress on Venereal Diseases

Las Vegas, Nevada, USA
November 16-17, 2017

Annual Congress on Fungal Infections, Diseases & Treatment

Atlanta, Georgia, USA
November 16-17, 2017

Annual Congress on Mycology

Atlanta, Georgia, USA
November 16-18 2017

Global Experts Meeting on Microbiology

Dubai, UAE
November 29-December 01, 2017

4th World Congress and Expo on Applied Microbiology

Madrid, Spain
04-05 December, 2017

Annual Summit on Clinical Microbiology

Dallas, Texas, USA
December 4-6, 2017

10th International Congress on Clinical Virology

Dubai, UAE
December 07-08, 2017

World Yeast Congress

Sao Paulo, Brazil
{10 Plenary Forums, 3 Days, 1 Event}
October 16-18, 2017

6th Annual Conference on Microbiology

Baltimore, USA
February 22-23, 2018

8th Global Summit on Microbiology & Infectious Diseases

Paris, France

Sterile Pharmaceutical Products Conference Speakers

Recommended Sessions

Related Journals

Are you interested in