Monitoring the storage conditions in the pharmacy is necessary to ensure that sterile products retain their respective quality attributes. Controlled-temperature storage areas such as refrigerators and freezers should be monitored at least once daily with results documented on a temperature log.
This section covers pharmacy’s responsibility for sterile commercial products and compounded preparations beginning when products are first received and continuing through compounding and waste disposal. To ensure both preparation quality and public safety, correct storage and handling procedures are necessary every step of the way. Sterile Components
Components are comprised of active and inactive ingredients, intermediate containers (e.g., a syringe used to transfer a drug from one container to another), final containers and closures. A procedure should specify the visual inspection of commercially available drug products, sterile ready-to-use containers, and devices (e.g., syringes and needles) upon receipt in the pharmacy. All items must be free from defects, within the
manufacturer’s expiration dating, and suitable for their intended use. USP Storage Conditions
Intravenous solutions, sterile commercial product, and sterile supplies should be stored according to manufacturer labeling or USP product monographs to preserve stability of ingredients. Most sterile products are aqueous solutions for which hydrolysis is the most common chemical degradation reaction. In general, the rate of a chemical reaction increases exponentially for each 10° C increase in temperature. Thus, storage of a beta- lactam antibiotic solution for one day at controlled room temperature will have an equivalent hydrolytic effect of approximately 3 to 5 days in cold temperatures. Cold temperatures may cause harm as well, for example refrigeration may cause harm as well, for example refrigeration may cause precipitates and freezing may break an emulsion or denature proteins.
Recommended storage conditions are usually stated on a product’s label and may include a specified temperature range or a designated place (e.g., “refrigerate”). Supplemental instruction (e.g., “protect from light”) should also be followed carefully. If a preparation must be protected from light and is in a clear or translucent container enclosed in an opaque outer covering, this covering should not be removed until the contents are to be used.
In the absence of specific instructions, a sterile product should be stored at controlled room temperature away from excessive or variable heat, cold, and light, e.g., away from heating pipes and fluorescent lights.
Clarifying Controlled Room Temperature
Since controlled room temperature may range from 15° C to 30° C, such storage may not be adequate for certain temperature-sensitive drugs. Clinically important changes can result from only a 5° C variation in room temperature over the shelf life of a preparation. Alterations in temperature-related drug stability could potentially compromise an
interpretation and assignment of beyond-use dates to compound preparations. Therefore, USP has further defined controlled room temperature:
“Controlled room temperature…encompasses the usual…working environment of 20° C to 25° C (68° to 77° F)…that results in a mean kinetic temperature
calculated to be not more than 25 degrees; and that allows for excursions between 15 and 30 degrees C (59° and 86° F)…in pharmacies, hospitals, and warehouses. Monitoring Storage Conditions
To ensure that the potency of a sterile commercial product is retained through its expiration date, pharmacy personnel must monitor drug storage areas. Controlled
temperature areas like refrigerators, freezers, and incubators should be monitored at least once daily and the results should be documented on a temperature log. A continuous temperature recording device or a thermometer with adequate accuracy and sensitivity may be used if properly calibrated at reasonable intervals.
On each day, pharmacy personnel should verify that the recording device is working and that temperatures are within the desired range. The temperature-detecting mechanism should be carefully placed so that it accurately reflects the unit’s temperature. The pharmacy personnel must also monitor conditions that cause temperature fluctuations such as frequent or extended opening of refrigerator doors.
Outside the Pharmacy
While compounded sterile preparations are within the confines of a clean-room, storage and other handling conditions can be largely controlled. Since sterile preparations must be transported for use in various patient care settings, their handling outside the pharmacy also must be considered. Efforts must focus on the acceptable focus on the acceptability of the sterile preparation for patient use (including stability of ingredients and sterility) and also on the reduction of waste and preparation costs. Key factors to consider include the transfer of sterile preparation form the sterile compounding area, storage conditions during transport and in the storage conditions during transport and in the patient care setting, and methods for return, recycling, and disposal. USP chapter <797> states that pharmacy is responsible for ensuring that compounded sterile preparations maintain their quality until administration to the patient. All personnel (including couriers and other non-pharmacy staff) who package, handle, transport, and store compounded sterile preparations outside the pharmacy must be appropriately trained so that this expectation is met.
Quality Control
Quality control is the day-to-day assessment of all operations from the receipt of raw materials to the distribution of the finished product.
Quality assurance is an oversight function, involving the adjusting of quality-control procedures and systems, with suggestions for changes as needed.
Each pharmacy should have written procedures covering the following: • Handling and storage
• Preparing admixtures • Labeling
• Transportation of IV fluids to the floors
Personnel involved in the preparation of IV admixtures should be trained and monitored on a regular basis. For quality control, documentation is essential and should include:
• Documentation of training and procedures • Quality control results
• Laminar airflow hood certification • Production records
• Concentration of all preparations
Final Exam
Directions: Select the most appropriate answer from the choices given.
1. Which of the following is not an injectable route of administration? a. Sublingual
b. Intravenous c. Intramuscular d. Subcutaneous
2. While the majority of perenteral products are prepared using commercially available medications and diluents, pharmacy departments still perform intravenous manufacturing.
a. True b. False
3. According to the Scope of Pharmacy Practice Project, ___% of a pharmacy technician’s time is spent collecting, organizing, and evaluating information. a. 20%
b. 22% c. 26% d. 35%
4. According to the Scope of Pharmacy Practice Project, the second most time consuming function, ___%, involve preparing, dispensing, distributing, and administering medications.
a. 35% b. 21% c. 24% d. 18%
5. Pharmacy technicians must possess which of the following basic requirements to participate in sterile compounding?
a. A working knowledge of the policy and procedures manual for compounding, dispensing, and delivering sterile products.
b. Adequate training and adherence to hygienic and aseptic techniques. c. Knowledge and awareness of the proper methods to store label and
dispose of drugs and supplies. d. All of the above.
Final Exam
6. The level of difficulty of preparing the compounding prescription is determined by _________________________________.
a. The physical properties of the drug being prescribed. b. The dosage form desired either by the prescriber or patient. c. Both a and b.
d. Neither a or b.
7. Sterile compounding is an advanced pharmacy technique that is part of the general education for a pharmacy technician and does not require additional training.
a. True b. False
8. The pharmacist maintains control over all pharmacy activities and the ultimate responsibility rest with him or her.
a. True b. False
9. The objective of formulating and compounding sterile preparations is: a. State laws
b. Food and Drug Administration (FDA) regulations c. Both a and b
d. Neither a or b 10. Adulteration is:
a. When two drugs that are only compatible with another drug are compounded together.
b. When the methods used in, or the facilities or controls used for
manufacturing, processing, packing, or holding do no conform to current good manufacturing practice.
c. Expired drugs d. None of the above.
11. When formulating and compounding sterile preparations, the technician must follow:
a. Federal Regulations b. State laws
c. Professional standards d. Written procedures e. All of the above.
Final Exam
12. As a technician, your work must be checked by a licensed pharmacist. Dispensing pharmacist must inspect and approve or reject all formulas, calculations, substances, containers, closures, and in-process materials. a. True
b. False
13. Technicians who compound batches of parenteral preparations must follow a master formula sheet to reproduce preparations that meet all purported norms. a. True
b. False
14. An ingredient is only considered a component of a compound if it appears in the final preparation.
a. True b. False
15. For parenteral preparations, the most common vehicle is: a. Water
b. Dextrose
c. Sodium Chloride
d. Lactated ringer’s injection
16. Sodium chloride injection 0.9% solution that is sterilized and packaged in a single-dose container is sold in no larger than ______ml size.
a. 30ml b. 100ml c. 1000ml d. 1500ml
17. All of the following are Water-Miscible Solvents except for: a. Ethyl alcohol
b. Liquid polyethylene glycol c. Propylene glycol
Final Exam 18. USP specifies that fixed oils must be:
a. Vegetable in origin b. Odorless
c. Have no rancid taste d. All of the above.
19. Solutes may be active ingredients or added substances. a. True
b. False
20. An antimicrobial agent may be effective in one formula of ingredients but not in another.
a. True b. False
21. _____________ stabilize a solution against degradation. a. Solutes
b. Antimicrobial agents c. Buffering agents d. Antioxidants
22. ______________ help to prevent oxidation of the component drug. a. Solutes
b. Antimicrobial agents c. Buffering agents d. Antioxidants
23. _________________ enhance the effectiveness of antioxidants. a. Chelating agents
b. Tonicity agents c. Solubilizers d. Emulsifiers
Final Exam
24. ___________ are used to suspend tiny oil globules in water to create an emulsion that contains a uniformed concentration of the active drug throughout the volume of the liquid.
a. Chelating agents b. Tonicity agents c. Solubilizers d. Emulsifiers
25. The closure is part of the container. a. True
b. False
26. ______________ containers permit withdrawal of successive portions of their contents without changing the strength, quality, or purity of the remaining portions.
a. Single-dose b. Multiple-dose
27. ___________ is the most popular material for sterile preparation containers. a. Glass
b. Plastic
28. ____________ is a parenteral formulation that is injected directly into the vein.
a. Intravenous b. Intramuscular c. Intradermal d. Subcutaneous
29. ___________ is a parenteral formulation that is injected into the substance of the skin.
a. Intravenous b. Intramuscular c. Intradermal d. Subcutaneous
Final Exam 30. A solution having a pH of 7 is ____________.
a. Acid b. Alkalinity c. Neutral
d. All of the above.
31. If sterile water for injection is the vehicle in a formulation, the risk of pyrogens in water is eliminated.
a. True b. False
32. Because numerous factors affect the stability of drug molecules, the choice of packaging is not important.
a. True b. False
33. With a Laminar Flow Hood, the orientation of the direction of airflow can be: a. Horizontal
b. Vertical c. Either d. Neither
34. ___________ cabinets are totally enclosed, vented, and gastight units. Operations are conducted through attached rubber gloves, and the cabinet is maintained under negative pressure.
a. Class II b. Class III c. Both a and b d. None of the above
35. If a Laminar Flow Hood is turned off, it is recommended to run for at least ___ minutes before using the work surface area in order to replace the room air with clean filtered air.
a. 10 minutes b. 20 minutes c. 30 minutes d. 40 minutes
Final Exam
36. Laminar Flow Hoods should be inspected and certified every year. a. True
b. False
37. The finer the needle, the higher the gauge number will be. a. True
b. False
38. In the selection of an appropriate syringe, as a rule the capacity of the syringe should be the next size smaller than the volume to be measured.
a. True b. False
39. All vials should be swabbed with 70% isopropyl alcohol before needle entry and left to dry. The swabbing is effective because:
a. The alcohol acts as a disinfecting agent.
b. The physical act of swabbing in one direction remove particles from the vial diaphragm.
c. Both a and b d. None of the above
40. Ampuls are closed-system containers, since air or fluid cannot pass freely in or out of them.
a. True b. False
41. Contamination can be caused by the following factors: a. Environment
b. Equipment c. Personnel d. All of the above
42. When laminar airflow is accessible to all sides of an object, the “zone of turbulence” extends approximately __ times the diameter of that object. a. 3
b. 5 c. 10 d. 12
Final Exam
43. __________ is the most common means of contaminating a pharmacy- compounded sterile preparation.
a. Air flow b. Expired drugs c. Touch
d. Dirt in the clean room
44. When wearing gloves, there is no longer a need for hand washing. a. True
b. False
45. To ensure fluid transfer into the IV bag, a needle longer than ⅜ inch should be used.
a. True b. False
46. The order in which drugs are added to the solution may be a factor in compatibility.
a. True b. False
47. Drug labeling is required if:
a. The compounded sterile preparation is not administered immediately b. If it is administered by someone other than the person who prepared the
medication. c. Both a and b d. None of the above. e.
48. Certain dosage forms do not need the route of administration on the label because it is implied.
a. True b. False
Final Exam
49. Controlled-temperature storage areas such as refrigerators and freezers should be monitored at least:
a. Daily b. Weekly c. Monthly d. Annually
50. Each pharmacy should have written procedures covering: a. Handling and storage
b. Preparing admixtures c. Labeling