Sample Medical Paper on Pharmaceutical Compounding-Sterile Preparations

Pharmaceutical Compounding-Sterile Preparations


Pharmaceutical compounded-sterile preparations generally outline the objective of describing the conditions and practices that prevent the death that results from non-sterility, excessive bacterial endotoxins, unintended chemicals contaminants, variability in the strength of correct ingredients and incorrect types and qualities of ingredients in compounded sterile preparations (CSPs). However, there specific practices and quality standards that should be followed during the preparation, storage, and transportation of CSPs (Chapter, 1).CSPs are preparations containing nonsterile components or devices that require sterilization before administration and the process involves the following:(1) Biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals. These should free from bacteria and other microorganisms when administering them to the patients.(2) Manufactured sterile products. These are prepared according to the product package inserts. (Chapter, 2).In contrast, there is no mixing or reconstituting the compounded components as indicated by the manufacturer’s direction in the approved labeling. This is because approved labeling rarely describes environmental quality such as International Organization for Standardization (ISO) class air classification and the amount of exposure.

Roles of compounding Personnel

Personnel responsible for compounding play a great role by ensuring proper identification, measurement, dilution, and mixing of CSPs. Additionally, the compounded sterile preparations should follow all the logistics of purification, packaging, storage, and distribution to the point-of-use in good condition. Proper labeling for clinical administration then follows it. Healthcare professionals ensure that the sterile products are manipulated aseptically, check for correct identity, quality, and the purity of ingredients. They also ensure that opened ingredients that are used subsequently are properly kept in a restricted access conditions in the facility, and ensure that all the sterilization methods meet the sterility criteria of CSPs as well as maintaining the strength of active ingredients (Chapter, 7). However, the compounding personnel has to ensure that temperature requirements of all the CSPs are followed. Any variations in the recommended temperatures for CSPs medium affect the components of the active ingredients present in the CSPs.

Classification of Compounded Sterile-Preparations Risk-Levels

Risk levels are appropriately assigned according to corresponding probability of contamination with organisms, spores, endotoxins, and chemicals. These characteristics serve as a guide and are not prescriptive.

Low-Risk Level. This is the level whereby products are created with aseptic manipulations in order to fit the unique need of the patients. ISO class 5 quality air is used as a criterion for compounding the pharmaceutical products. A media-fill test procedure has to be performed by authorized person by measuring and mixing manipulations in closed or sealed packaging systems. To enhance quality assurance, the compounding personnel have to conduct daily disinfection procedures in order to kill the microorganisms that may be present at the compounding environment (Rich & Darryl, 284-292).

Medium-Risk Level. Under this category, it involves all low-risk level conditions and multiple individual and small doses of sterile conditions mixed for the preparation of a CSP to be administered to several patients or one patient on multiple occasions. The appropriate process for compounding at this level uses both manual and automated techniques. Quality assurance for medium-level risk involves routine disinfection of the direct compounding environment that ensures the minimization of microbial contamination, reviewing all product to make sure that correct identity and amounts of ingredients were compounded and carry out a visual inspection of products to ensure that there are no particulates in solutions (Rich, 288).

High-Risk Level. All the sterile and nonsterile ingredients and the mixtures that are subjected to air quality inferior to ISO class five. The process involves dissolving the compounded non-sterile drug and the powdered nutrients. However, the quality assurance for high-risk level uses the criteria of visual conformation ensuring that the personnel tasked with compounding is in appropriate protective gear (Moore & Markus, 342).

Compounding Accuracy and Sterilization verification

The methods used for sterilization process  for CSPs should correspond to the verified  sterilization document in the facility. The process of verification is used to measure the effectiveness of  sterilization procedures  as well as check for the purity of  CSPs ingredients. For instance, sterility testing is carried out to medium risks compounded sterile preparations whereby biological indicators are added to the specimens in a test to determine the adequacy of the sterilization cycle. For accuracy, the degree of concentrations and the level of ingredient’s purity are indicated on the package labels. Therefore, the compounding person has to observe and use the correct measurement device for the analysis. However, some ingredients are not indicated on the labels such as the expiration date for the bulk drug substances hence a test is required to check for the correct proportions of  active ingredients for the products before use.

Immediate-Use of CSPs

The CSPs are recommended during an emergency when a patient requires immediate administration of the CSPs. It is widely used when cases such as cardiopulmonary resuscitation and urgent treatment in the emergency arise. It is during these special circumstances that CSPs has to be recommended immediately to the patients. However, delaying patient’s therapy may cause health problems to an extent of resulting in the death of the patient while the preparations of the CSPs are underway.

Methods of Sterilization

Qualified healthcare professionals have the appropriate knowledge and skills necessary for supervision of compounded sterile preparations. It is in the line of their professional duty to assess and make recommendations for the best sterilization methods considered appropriate for a particular health care setting.  There are clearly laid down general guidelines outlining the matching criteria of CSPs. Moreover, by considering the compounding environment, the healthcare professionals utilize the appropriate methods that involve the sterilization of CSPs by filtration, steam, and dry heat method.

Sterilization by filtration

This involves the use of approved commercial filters. The filters are sterilized initially before the processing of CSPs. Preferred  filters should have a minimum nominal size of a pore of 0.2 μm. The staffs in charge of compounding ensure that the filters have the correct amount of chemicals, pressure, and temperature conditions. Additionally, it is recommended  to use  the correct volumes in order to achieve sterility of the pharmaceuticals. This will result in the maintenance of the strength of the ingredients of the CSPs.

Sterilization by steam

This is the use of saturated steam subjected at very high temperatures (autoclaving). Steam sterilization is mostly applicable to the aqueous CSP  that retain both their chemical and physical states under high-pressure conditions. For sterility, the materials are subjected to a steam at a temperature of 121˚ c. the preparation before sterilization process involves wrapping all the glass and plastic material with fabrics. The solutions are then passed through sterilizing filters whereby the particulate matter is removed.

Sterilization by dry heat

Sterilization by heat is performed in an oven specifically designed and modified for sterilization purposes. A blower in the oven distributes the heated air  throughout the oven chambers. The process requires a long exposure of the compounded material to a high temperature for a longer period than in the steam filters. Biological indicators such as Bacillus subtilis is used to measure the effectiveness of the sterilization process. For this method, the sterilization process should be given more time before the measurement of the sterilization. This is because this time is used to determine every load processed. However, after reaching the phase of heat sterilization, care should be taken to prevent the contamination of the sterilized materials during the cooling process. This is achieved by sterilizing all the cooling fluid and gasses that are used in the cooling process.

Environmental Quality and Control

Compounded sterile preparations require freedom from any form contamination. Sterility of  CSPs  depends on the environment conditions exposed to and the performance process. Any exposure to critical sites  such as the beakers may expose the CSP  to contamination. Furthermore, the nature of the site a CSPs is exposed to affect the degree of contamination of the preparations. Therefore, there should be regular disinfection of the surfaces and the zoning of critical sites by limiting physical contact from visitors and unauthorized persons in order to provide a free environment from contamination for the compounding practice. Furthermore, ISO class 5 air sources such as buffer areas ensure restriction on the compounding environment. The access to these Ante-areas is limited to compounding personnel and the facility cleaners.

Facility Design and Environmental Controls

The facilities where compounding takes place are well physically designed to reduce contamination from coming into contact with critical sites. There are basic recommendations that are required for a compounding facility. These include well-lit working areas, moderate temperatures of 20˚ that ensure comfortable working condition for the compounding personnel. Additionally, the engineering controls to ensure the maintenance of ISO class 7 conditions. High-Efficiency Particulate Air (HEPA) filters are also used to maintain a comfortable working environment.

Standards Operating Procedures(SOPs)

It is a requirement for all compounding facilities to have SOPs that ensures the provision of a quality environment for the preparation  of CSPs. The  SOPs recommendations restrict buffer areas to qualified personnel, ensure that trolleys that bring supply are controlled in the ante-area by disinfecting them before they are allowed in the compounding area, and ensure that the compounding procedures are carried out well to minimize contaminating the ingredients and observe all the ISO classes 5 and 7 air quality.

Beyond-Use dating and Storage

Beyond-use dating(BUD) is specifically given by the pharmacy for a sterile product. The BUD for compounded sterile products is used to identify the time within which a compounded  should be used when it is prepared or mixed  before the degradation of the ingredients. After the BUD, a CSPS cannot be administered to a patient. However, to  maintain beyond use dating, time and temperatures during the CSPs cycle should be controlled. On the other hand, CSPs should be stored  according to the manufacturer’s recommendations towards the products’ ingredients.


Pharmaceutical compounding sterile preparations seek to restore the health of the patients. Therefore, care should be taken to ensure those bacterial endotoxins and other hazardous chemical contaminants are fully scrutinized during the preparations. To maintain the sterility of CSP depends on the environment anticipated during the preparation. Controlling the environmental conditions for each level of risk will result in a sterile production of CSPs and ensures maintenance of the components of the active ingredients in an appropriate form. The purity and accuracy of sterile products start from the personnel handling the ingredients, environment, sterilization methods used, the design of the facility, standards operating procedures, storage practices, dispensing practices and the quality assurance program. Therefore, the compounding personnel and the facilities  should practice proper handling of the compounded sterile product for minimal contamination and a provision comfortable working areas for the compounding personnel respectively,



Works Cited

Chapter, USP General. “797> Pharmaceutical Compounding–Sterile Preparations.” The United     States Pharmacopeia (2004).1-36.Print.

Moore, Jeffrey C., John Spink, and Markus Lipp. “Development and application of a database of             food ingredient fraud and economically motivated adulteration from 1980 to 2010.”      Journal of Food Science 77.4 (2012):336-374.

Rich, Darryl, et al. “Guidelines for the safe preparation of sterile compounds: results of the ISMP             sterile preparation compounding safety summit of October 2011.” Hospital pharmacy      48.4 (2013): 282-294.

Sterilization, U. S. P. “Sterility Assurance of Compendial Articles, ch. 1211.” (2000).25