Introduction

| Home | | Pharmaceutical Microbiology | | Pharmaceutical Microbiology |

Chapter: Pharmaceutical Microbiology : Sterile Pharmaceutical Products

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


STERILE PHARMACEUTICAL PRODUCTS

 

INTRODUCTION

 

Parenteral drug delivery systems and many medicinal products, such as dressings and sutures, must be sterile in order 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 micro-organisms 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, and certain surgical dressings, as well as instruments necessary for their use or administration, must be presented in a sterile condition.

 

Although there is always a chance of an idiosyncratic reaction between a medicine and a patient caused by sensitivity, allergic reaction or unwanted side effects, 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, protozoa or 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.

Contact Us, Privacy Policy, Terms and Compliant, DMCA Policy and Compliant

TH 2019 - 2022 pharmacy180.com; Developed by Therithal info.