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I. INTRODUCTION

Aseptic technique is a general term involving practices that minimize the introduction of microorganisms to patients during patient care. There are two categories of asepsis; general asepsis which applies to patient care procedures outside the operating theatre and surgical asepsis relating to procedures/processes designed to prevent surgical site infection.

Aseptic techniques are used to reduce the risk of post-procedure infections and to minimize the exposure of health care providers to potentially infectious microorganisms. Aseptic techniques include practices performed just before, during, or after any invasive procedures. Poor adherence to aseptic techniques results in considerable morbidity and mortality. Even in countries with well-established infection control programs, Hospital-acquired infections (HAI) related to poor compliance with aseptic techniques is an important public health problem.

It is important that all health care facilities establish policies regarding procedures that require aseptic techniques. Health care personnel who perform these procedures should be trained in aseptic technique and it is particularly important for staff to understand why aseptic techniques are needed and for the hospital director to ensure that Adequate equipment and supplies are available. Supervision and monitoring of infection control activities is a critical element of infection control

Aseptic techniques are practiced for all invasive medical procedures. Types of Hand washing and gloves are different according to the procedure performed. Most disease transmission occurs due to actions of health Care personnel (HCP) that ignore basic concepts of aseptic techniques such as the reuse of syringes/needles, the touching of a sterile device onto a non sterile Surface and the entering of a sterile solution without adequate Decontamination of the port of entry.

a.	ASEPTIC PROCESSING OBJECTIVE •	The main Objective is to maintain the sterility of a product, assembled from sterile Components, Operating conditions so as to prevent microbial contamination

•	To review specific issues relating to the manufacture of aseptically prepared products:

	Manufacturing environment

	Clean areas

	Personnel

	Preparation and filtration of solutions

	Pre-filtration bio-burden

	Filter integrity/validation

	Equipment/container preparation and sterilization

	Filling Process

	Validation of aseptic processes

II. DESIGN OF ASEPTIC AREA 1.	SITE OF PREMISES: Aseptic area should be designed at a site away from stairs, lift corridors and general manufacturing area as these areas are capable of providing routes by which microorganisms may travel. Each stage of the production should be carried out in separate rooms of aseptic area. Store rooms should be adjacent to aseptic area where all sterile equipments and products can be stored. Washing and changing rooms should be located before the entrance of aseptic area. Even some space should be provided for keeping records, label-writing, inspection and finishing of products. 2.	SIZE OF PREMISES Aseptic area should e constructed in such a manner that maximum number of personnels can work at a time. The rooms should be large and spacious by which overall effect of microorganisms can be reduced which ultimately results in minimal contamination. The ceiling of rooms should be at a low height which facilitates in its easy cleaning. In large rooms, heat-sterilized injections and particle free solutions are prepared. In small rooms the equipments which help in controlling microbial content, temperature and humidity are placed. 3.	 WINDOWS: Large windows with transparent glass are suitable for aseptic area. These windows should remain closed and ventilation should be provided artificially by air filtration system. Windows should be double-glazed wherein is inner sheet is fixed and outer sheet can be opened for cleaning. Those types of windows are used to prevent heat loss from glass material. Fig.1 Windows in aseptic rooms

4.	 DOORS Entrance should have double doors an air-lock system. In this way, air entering from outside into the aseptic area can be prevented. Even sliding and swing doors can be used. Fig. 2 Doors in aseptic rooms

5.	FLOOR, WALLS AND BENCH TOPS The floor, walls and bench tops should be, 	Easy to clean 	Smooth with no cracks and pores 	Impervious to cleaning agents like disinfectants etc 	Chemically resistant to solvents, dyes, strong acids or alkalis. FLOOR- It should be made up of the following materials, i.	Terrazzo – It is a mixture of cement and marble (crushed) which is mostly used as flooring material in aseptic area. It is available as tiles or can even be spread in plastic form. Advantages 	It can withstand harsh cleaning. 	The water used for cleaning purpose can be removed easily by sloping the floor towards the gully, which is present at one side of the aseptic room. Disadvantages 	Expensive. 	Noisy cold and gets slippery when wetted. 	It gets easily marked by moving rubber wheels 	It gets easily attacked by acids. 	It gets easily stained by dyes. ii. Linoleum- Linoleum of heavy grade is best suited for flooring. It is     available in the form of sheets  and tiles. Sheets are more preferred than tiles as the tiles consist of joints and surface irregularities which can trap dust particles. Advantages 	Easy to clean. 	Inexpensive 	Warm, comfortable and quiet. 	Available in many colors Disadvantage- polished surface gets slippery when wetted iii. PLASTIC-POLYVINYL CHLORIDE (PVC) of non-slip and matt-finish grade is ideally for septic area. They are available in the form of sheets and tiles. The joints of sheets and tiles can be welded. Advantages 	Easy to clean. 	Inexpensive 	Available in many colours Disadvantages 	The polished surface gets slippery when wetted 	Easily attacked by oil and organic solvents 	Gets easily stained by dyes 	Less comfortable compared to heavy grade linoleum as they are more thin in nature.

6.	WALLS AND CEILING They should have surface made up of i.	TILES- they are smooth, non-absorbent in nature and tend to crack on prolonged usage. They can be easily cleaned. Modern tiles have replaced traditional tiles due to their good quality. However, dust might accumulate in cavities of tiles due to breakage of intermediate cement. ii. GLASS PAINT- This type of paint is applied on smooth plaster. It provides good protection when new but upon cracking or peeling the paints has to be reapplied. These plaster walls get easily damaged. iii. PLASTIC LAMINATE-This type of material is used to cover the walls and ceiling of an aseptic room. However, it is expensive.

7.	TOPS OF WORKING BENCH: The tops of the working benches should be made up either of the following materials. i.	STAINLESS STEEL: It  is durable in nature. The screws used in benches should be located under  the  surface of the bench to avoid accumulation of the dust. ii. PLASTIC LAMINATES: They are available in various bright colours. One complete sheet of plastic should be used to make the surface of a bench. Advantages: 	Low cost and less noisy compared to stainless steel. 	Resistant to reagents (except strong solution of phenol). 	Resistant to heat. Disadvantage: 	May get stained with dyes.

8.	ENVIRONMENTAL CONTROL: The environmental control maintained is different for areas (clean-up area, compounding area, filling and packaging areas). Stringent environmental control is required before and during the processing of parenterals to assure an area free from contamination and where there is no accumulation of dust particles, lint, viable microorganisms etc. Production environment is constantly monitored and evaluated to assure that the required aseptic conditions are maintained. If any discrepancy is noted in the action levels, then possible corrective measures should be taken. Various evaluation test are available to evaluate the environmental control. a)	PARTICLE COUNT: The number of particles in a volume of air sample is measured by particle measuring systems which not only count the particles but also provide size distribution details based on the magnitude of light scattered by the particles. This instrument although detects all forms of particulate matter but fails to differentiate between viable and non-viable forms. b)	SLIT-TO-AGAR(STA) SAMPLER: This device consists of a rotating agar plate comprising of a slit through which measured amount of air is accumulated by applying vacuum. This air comes in contact with the surface of the agar plate. Viable microorganisms stick to the agar plate and start growing in the form of colonies that are counted as colony forming units c)	RODAC PLATES: These plates consist of nutrient agar with a convex surface which is rolled on the surface to be tested. Microorganisms stick to the surface of agar following which the plates are incubated.

9.	TRAFFIC CONTROL: Traffic refers to supply of materials, entry and exit  of workers etc., in the production area of aseptic room. Traffic should be strictly controlled in aseptic area. A prescribed procedure should be followed, which should be applicable to every person who enters the aseptic area. The personnel can enter an aseptic area only after passing through an air lack. Before entering, they should change their clothes, wear fresh sterile gowns, cover their faces with masks, wear hand gloves, head covers or caps and shoes. Once a person enters the aseptic area, then he/she cannot leave until the manufacturing cycle gets completed. Entry of unauthorized persons in this area should be restricted. 10.	 GENERAL CLEANING: Microbial and particulate contamination can be sourced not only from the clothes of operators but also from other sources. In order to minimize this microbial contamination, measures adopted for cleaning should be strictly imposed. A cleaning schedule should be developed and followed on a daily or monthly basis, based on sterility requirements. Separate workers should be appointed for maintenance and cleaning of all the equipments, walls, ceiling and floors before and after the completion of production cycle. Walls, floors and roofs of aseptic area should be constructed in such a way that it should facilitate ease of cleaning. Apart from this, even operators should wash their hands with cetrimide or chlorhexidine detergent before entering the aseptic area. Sanitization is carried out using disinfectants or UV radiation before starting the production in two ways: a)	By spraying a suitable liquid disinfectant over all the surfaces in aseptic areas. However surface disinfection by wiping surfaces with liquid disinfectant is more preferred. b)	The aseptic area is irradiated to decrease the population of bacteria. It is carried out by cold cathode mercury vapour lamp which gives maximum UV radiation. As these rays are harmful, the persons are not allowed to come in contact with them. Hence, direct irradiation is carried out only when aseptic area is vacant.

11.	CLEAN ROOMS: Since it is prerequisite for parenteral products to meet extremely high standards of          cleanliness and purity, the environment in which those preparations are manufactured have been classified and assigned with standard designations by the United States European countries and the International society of Pharmaceutical Engineers. These specifications are based on the maximum allowed number of air-borne particles/feet cube of 0.5micrometer or larger and 5micrometers or larger. Table No. 1 Specifications of clean rooms Maximum number of particles/ft3,                                                    less than or equal to 0.5micro metres	 Maximum number of particles/ft3, less than or equal to 5micro meters	International Society of Pharmaceutical Engineers	United States classification	European grade 350 3,500 350,000 3,500,500	0 0 2000 20,000	Critical Clean Controlled Pharmaceutical	100 1000 10,000 100,000	A B C D Since many of the parenteral products manufactured in one country and distributed globally, therefore the quality of air, quality of aseptic areas should meet both the United States and European specifications. The major differences between European and US standards are: •	European countries assign grades A, B, C, D for different areas rather than class 100, 1000 etc; •	They use particle and microbial limits per cubic meter rather than per cubic foot. •	They measure particles at 5micrometer in addition to 0.5micron in grade A & B areas. •	They differentiate area cleanliness both during processing and at rest. Normally, the classification used in pharmaceutical practice range from class  100,000(grade D) to class 100 a)	CLASS 100: Class 100 clean room is defined as an area in which the particle count in the air is not more than 100/cubic ft of 0.5micrometer and larger in size. This level of cleanliness is achieved by HEPA filters which blow the effluent air along parallel lines (laminar air flow) at a uniform velocity of 90-100ft/min Class 100 work environments are specified for the most critical aseptic filling, sealing, and cleaning operations only, because it is expensive and requires effective maintenance and monitoring. b)	CLASS 1000: This clean room is defined as an area consisting of not more than 1000 particles of0.5micrometer and larger per cubic foot. This is an buffer area between the critical (class100) and controlled (class10000) area wherein maintenance of strict aseptic conditions are not required but control of microorganisms and particulate matter should be stringent. This level of cleanliness is essentially maintained in compounding area to control the dust generated due to weighing and compounding operations. c)	CLASS 10,000: This room is the one in which the particle count is not more than 10,000per cubic foot of 0.5micrometer and larger in size This kind of clean room is also a buffer area in which operations such as handling of pre-cleaned containers and aseptic gowning of the personnel is performed

d)	CLASS 100,000: The particle count of his room should not be more than 100,000 particles/cubic foot of 0.5micrometer and larger in size. Material support area, stock staging area and finishing and packaging area which do not require stringent requirements of cleanliness like aseptic area fall under class 100,000 This area is constructed to withstand moisture, steam and detergents as preparations for the filling operation such s cleaning and assembling of equipment is undertaken  here.

Fig. 3 Clean rooms

12.	RISK LEVELS IN STERILE COMPOUNDING The USP 24/NF19 Section Sterile Drug Products for Home Use and ASHP Technical Assistance Bulletin on Quality Assurance for Pharmacy-Prepared Sterile Products define three Risk Levels of Sterile Compounding. These Risk Levels might be summarized as follows:

Table No.2 Risk Levels and Associated Risks in Sterile Compounding Risk Level	Risks Low Risk	• product is compounded with commercially available components • compounding involves few aseptic manipulations ”closed system” transfers are used High Risk, Category I 	• prepared from commercially prepared compounds • closed system pooling of sterile drug products • complex, numerous manipulations over a long period of time • multiday infusion via a portable pump or reservoir High Risk, Category II	• prepared from non-sterile drug substance • “open systems”

13.	CLEANING OF AIR: The greatest source of contamination is the air which enters the aseptic area, as it contains most forms of microorganisms. Thus, it is important to clean the air before it enters the aseptic area to avoid contamination. a)	 LAMINAR FLOW SYSTEMS           Class 100 clean rooms (aseptic rooms) can be achieved by laminar flow systems in which clean air is obtained by passing it through HEPA filters which are the most efficient cleaning device. The clean air flows at a uniform velocity of 100+/- 20ft/min and simultaneously sweeps the dust particles and makes the entire area of the aseptic area of the aseptic room free from dust particles. Examples of commercially available laminar flow systems are clean air, Clestro, Liberty, Air control, Laminaire etc;      Types of laminar air flow systems: Laminar air flow systems are generally of three types. i.	VERTICAL FLOW SYSTEM: This system consists of false floor and false ceiling. The air is filtered through pre-filters, electrostatic filters and HEPA filters in sequence situated in the false ceiling. The filtered air is devoid of particles ranging from 0.1 – 0.3 micrometer even larger. This phenomenon of obtaining filtered air enters into the false floor through second set of HEPA filters. From the false floor, small proportion of filtered air is re-circulated  into the false ceiling through a re-circulation duct Advantages- 	During the handling of chronic and hazardous materials, the vertical air flow pattern provides protection to the operator against these substances. 	The operating area is provided with exhaust filters which remove the remaining portion of the air. This provides protection to the operator. 	It is more preferable when compared to horizontal air flow systems. Disadvantage- 	It is an expensive system as it requires double installation of HEPA filters Fig. 4 VERTICAL FLOW SYSTEM:

ii. HORIZONTAL FLOW SYSTEM: In this system, the flow of air is horizontal. The air is filtered through pre-filters and HEPA filters which are placed in the lateral walls. Some portion of the filtered air is re-circulated through a re-circulation duct Disadvantages- 	As the flow of air is directly focussed on the working area, therefore the process in operation cannot be considered as done under complete sterile conditions. 	During the handling of materials like antineoplastic drugs, this system fails to provide protection to the operator.

Fig. 5 HORIZONTAL FLOW SYSTEM:

iii. WALL TO FLOOR FLOW SYSTEM: The filtered area enters from the lateral wall with an inclined flow towards the floor. This system offers high aseptic conditions. Advantage- the system is portable Disadvantage- it is expensive Fig.6 wall to floor flow system

b)	 LAMINAR- AIRFLOW HOOD: The most commonly used laminar-air flow hood is unidirectional horizontal laminar- air flow cabinet. This system helps providing Grading A environmental conditions and also helps in maintaining sterile conditions. Horizontal airflow cabinet consists of coarse pre-filters, supply plenum chamber, HEPA filters, separators and pressure gauges.                   Fig. 7 laminar- airflow hood:

c)	HIGH- EFFICIENCY PARTICULATE AIR (HEPA) FILTERS: HEPA filters are primarily used for the sterilization of air. These can remove 99.99% of particles of size greater than 0.3micrometer. Hence, they can produce air free from dust particles and bacteria. These are employed in laminar air flow cabinets, overhead canopies, ducts, walls and ceiling panels.	HEPA filters consist of bank of filter medium and spacers. The filter medium up of sheets of glass microfibers separated and supported by spacers made up of aluminium. The filter material is sealed with aluminium frame and one side of the filter is protected with a mesh of coated mid steel. The pleated sheets of glass microfibers are places parallel to each other. This helps in increasing the surface area of the filter, thereby increasing the airflow through the filter. These HEPA filters help in maintaining the velocity of air at 23+/- 90cm/min. Fig. 8 High- efficiency particulate air (HEPA) filters Working- The work station (horizontal air flow cabinet) is placed in an aseptic area where the flow of air is minimum. The work station is started 15minutes prior to the actual operation. This is done to make the work station area free of particular matter. The fan forces the air through the HEPA filters which releases pure air into the area used for working purpose. The air during its course of flow through working area, sweeps away  the contaminants from the  walls, equipments, personnel etc. In this way, the contamination arising from the operator and the process itself is avoided during critical procedures Maintenance: HEPA filters are protected with the help of grills. These grills should be properly installed for proper functioning of HEPA filters. They should be changed on monthly basis. Filters should be replaced immediately if the velocity of air across the working surface area falls below 22 m/min. Operational efficiency and integrity of HEPA filters is monitored by dioctylphthalate (DOP) smoke particle penetration test. DOP smoke consists of very minute particle of size 0.34 which cannot pass through the filters. This particulars substance forms an invisible smoke. If the filter shows the presence of any leakage, then the smoke passes, through the filter and can be detected by smoke photometer. Even velocity of air should be maintained at 230+_ 90 cm/min. Any changes in the velocity of air can be detected by means of an anemometer. Every 6months laminar air flow hood is properly maintained, then it provides good aseptic environment Merits: 	They help in removing larger particles from air by inertial impaction process. 	They help in removing medium sized particles by direct interception process 	They help in removing smaller particles by Brownian diffusion 	They help in providing high flow rate of air 	They help in developing low pressure drop across the filter Applications: 	Laminar air flow systems employing HEPA filters are used in laboratories and pharmaceutical industries where a sterile working area is needed for preparing nutrient media, for carrying out assays and for the manufacturing of sterile parenteral preparations. 	Used for the treatment of exhausted air from microbiological safety cabinets 	Used in operation theatres and hospital isolation units like rooms occupied by burned patients to provide filtered air so as to lower the number of air-borne microbes 	Used in product applications like capsule filling, granulating, tableting. 14.	PERSONNEL REQUIREMENTS: Highly, Skilled Professional s and well trained workers should be engaged in the manufacturing of sterile preparations. If workers from non-professional background are employed, then training should be given according to GMP requirements. After training, the personnel should be evaluated for the knowledge and skills to ensure that adequate training has been provided. The personnel’s should also be e-trained on periodic basis to increase their levels of expertise. The personnel  employed should not be suffering from any infectious diseases and even dermatological conditions which might increase the microbial contamination. Periodic medical examination of all the employees or workers should be carried. The uniform of workers should be sterile and so designed that it should confine discharges released from the body. The personnel are required to wear fresh and sterile uniforms, head covers, shoe covers, face masks, goggles and gloves while working in the aseptic area. The gloves should be worn after the hands have been thoroughly scrubbed with a disinfectant. Fig. 9 Personnel requirements Dacron uniforms are uniforms are preferred as these are lint-free, confine the discharges and are comfortable. Moreover, air is occasionally directed over the personnel entering the aseptic area, which helps to blow off any lint from the uniforms. Conversation between the personnel working in aseptic area should be minimal. Inward and outward movement in aseptic area as well as within the area should be minimum. Minimum number of personnel must be employed for manufacturing sterile preparations in aseptic premises. Even the equipments coming into the aseptic area must be thoroughly cleaned by using disinfectants.

15.	GENERAL COMMENTS ABOUT ASEPTIC TECHNIQUES Guidelines recommend that Low Risk Level compounding be done in a Class 100 laminar flow hood. The High Risk categories require that a laminar flow hood be located in a Class 100,000 (Category 1) or 10,000 (Category 2) controlled area. In any of these cases, however, working in a laminar flow hood is not sufficient to ensure sterility. The hood does not provide sterility - just an ultraclean work area. Products will be placed in the hood for assembly or compounding that are either sterilized before hand or will be sterilized by filtration while in the hood. Personnel carrying out these procedures must use techniques to minimize the potential contamination (microorganisms, particulate material, pyrogens) possible during these manipulations. Aseptic technique can be defined as the sum total of methods and manipulations required to minimize the contamination of sterile compounded formulations. The following are considered minimum requirements for good aseptic technique: •	Conduct all manipulations inside a properly maintained and certified laminar flow hood. Allow the laminar flow hood to operate for at least 30 minutes before use in order to produce a particle free environment. Maintain a designated "clean" area around the hood. •	Remove all jewellery and scrub hands and arms to the elbows with a suitable antibacterial agent. Sterile gloves are worn in addition to scrubbing. •	Wear lint-free clothing or clothing covers, head and facial hair covers, and a mask. •	Clean all flat surfaces of the hood with 70% isopropyl alcohol, or other antibacterial scrub such as benzalkonium chloride solution, working from top to bottom, then from back to front. •	Assemble all necessary supplies in the hood checking each for packaging damage, expiration dates, and particulate material. Use only pre-sterilized needles, syringes, and tubing for medication transfers. •	Remove the dust covering from supplies before placing them in the hood. •	Be sure there are no objects between the HEPA filter and the sterile surfaces, and that there is adequate space between objects. Place the smaller supplies closer to the HEPA filter and larger supplies farther away from the filter. •	Swab all surfaces that require entry (puncture) with 70% isopropyl alcohol or betadine solution. Avoid excess alcohol or lint that might be carried into the solution. •	Give close attention to hand position and the direction of air flow over injection ports or objects being manipulated. Minimize hand movements within the hood. •	To assemble needles and syringes, peel back the protective coverings and attach the needle and syringe, twisting to lock in place. When handling syringes and needles, be sure not to touch any surface that will come in contact with the sterile solution. Only the exterior of the syringe barrel, plunger tip and needle cap or sheath may be safely handled. •	Do all manipulations at least 6 inches inside the outer edge of the hood. Do not remove the hands from the hood until the compounding procedure is complete and the final inspection of the formulation has been made. •	Examine all formulations before removing them from the hood. III. ASEPTIC PROCESSING IN PARENTERALS The production process includes all of the steps from the accumulation and combining of the ingredients of the formula to the enclosing of the product in the individual container for distribution. Intimately associated with these processes are the personnel who carry them out and the facilities in which they are performed. The most ideally planned processes can rendered ineffective by personnel who do not have the right attitude or training, or by facilities that do not provide an efficiently-controlled environment. To enhance the assurance of successful manufacturing operations, all process steps must be carefully reduced to writing after process steps are often called standard operating procedures (SOPs). No extemporaneous changes are permitted to be made in these procedures; any change must go through the same approval steps as the original written SOP. Further, extensive records must be kept to give assurance at the end of the production process that all steps have been performed as prescribed, an aspect emphasized in the FDA’s Good Manufacturing Practices. Such in process control is essential to ensure the quality of the product, since these assurances are even more significant than those from the product-release testing. The production of a quality product is a result of a continuous, dedicated effort of the quality assurance, production, and quality control personnel within the plant in developing, performing and confirming effective SOPs. To differentiate quality assurance from quality control, the former function is usually one of pre-planning those factors that bear upon the quality of a product and is thus a preventative development process. Quality control may include this aspect, particularly if there is only one organisational group directly responsible for quality in a plant, but it more likely concentrates on those operations and tests that have been designed to evaluate the quality actually achieved in a product. To enhance the visualization of the passage of materials through the various steps of the production process, a flow diagram is provided in Fig.10 In the initial step, the formula ingredients, container components, and processing equipment that have been released for use are drawn from their respective storage areas. The ingredients are compounded according to the master formula in an environment designed to maintain a high level of cleanliness. If the product is a solution, it is filtered during transfer to the aseptic filling room. Process equipment and container components are cleaned thoroughly according to the required specifications, are assembled in a clean environment, and preferably, are sterilized and depyrogenated prior to use. All equipment and supplies introduced into the aseptic filling area should be sterile, having come directly from the sterilization process, preferably through double-ended sterilizers. When this is not possible, packages, hose lines from equipment and supplies should pass through openings of minimal size that can be reclosed promptly, under aseptic conditions. Outer wrappings of packages should be loosened and the contents received, that is, the inner wrapping grasped, by personnel already in the aseptic room. When double wrappings are not feasible, the outer surfaces of boxes, packages or equipment should be wiped with a disinfectant solution as they are transferred into the aseptic room. All supplies must be introduced into the aseptic filling rooms in such a manner that aseptic state of these rooms are maintained, thereby preventing the introduction of environmental contamination into the product while it is being sub-divided into individual containers are sealed, contamination cannot enter the container and product. The product is sealed in its final container within the aseptic room. It is then transferred to the packaging area. This area is maintained clean but need not meet the standards imposed for the aseptic rooms or for the compounding room. Packaged products are placed in quarantine storage until all tests have been completed and in process control records have been evaluated; then the product may be released for distribution

Fig. 10 Diagram of flow of materials through the production department

Fig. 11 Aseptic process map

IMPORTANCE OF ASEPTIC TECHNIQUE Sterile preparations are considered to be high risk category products due to the increased risk and higher level of microbiological contamination for products prepared in uncontrolled environments 	Parenteral administration bypasses the skin and gastrointestinal tract, the body’s natural barriers to infection giving a patient a contaminated product can cause serious adverse effects including death 	Parenteral medications account for >40% of all medications administered in institutional practice 	 Preparation should take place in well controlled environment using well established quality assurance-driven procedures. This considerably reduces the risks associated with these product III. CONCLUSION: Aseptic techniques are defined as a set of procedures carried out to obtain an environment with minimal contamination from pathogenic microorganisms. These procedures are carried out under controlled conditions. The main goal of aseptic technique is to provide protection against infections. It also helps in controlling the spread of pathogens while other processes like cleaning, sanitization or disinfection are not efficient enough to prevent infection Design of aseptic area depends on the requirements and economic condition of the pharmaceutical industry. In industry, complex procedure like packaging of sterile powders from bulk into individual bottles (vials) is carried out by a team of workers. High standards should be of maximum degree in aseptic area whereas in other areas such as compounding area etc, cleanliness can be of low degree.

IV.REFERENCES:

•	Cooper and Gunn’s dispensing for pharmaceutical students 12th edition by  S.J.Carter •	 Katherine   hauswirth   APRN,  The group  inc.,  Gale,  Detroit,  2002 •	Aseptic technique Kristen charney medically reviewed. •	Lachman/ Lieberman’s The Theory and Practice of Industrial Pharmacy.