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Secondary engineering controls: surfaces

Focus on the surfaces is the key point of secondary engineering controls.
16.1
Within the secondary engineering control, the additional requirements are all surfaces should be smooth, impervious, free from cracks and crevices, and nonshedding. The surfaces include ceilings, walls, floors, shelving, cabinets, work surfaces. All junctures should be coved, which means angled to prevent a crevice. For example, the ceilings connect to walls, walls connect to walls, floors connect to walls.
62.3
Also, no dust-collecting ledges, pipes, or similar surfaces
72
Several points in cleaning and disinfecting are written standard operating procedure should be followed; 70% alcohol is required for wipe work surfaces.
88.6
The recommended cleaning frequency are all shelving, supply carts, and countertops monthly, floors daily, reusable cleaning tool need to be cleaned after each use.
109.4
Traffic control is another important issue, for example, flow of supplies and the movement of all personnel, including housekeeping personnel, require appropriate design and observation. The supply item included into Laminar Airflow Workbench or Biological Safety Cabinet is another important source of contamination. To make sure the environment is up to standard and well-maintained, environmental testing program should be developed.
148.8
Several points for environmental testingneed to be considered.
153.3
Number 1: The purpose of the program is that to verify the control is achieved and maintained.
162.5
Number 2: Detecting the presence of microbial contaminants.
167.7
Number 3: Baseline value should be established and, then, a regular monitoring program could be performed. To detect the loss of control need to be evidenced byincrease in the microbial counts. If there is any incidence, determine the causes and correct them
194
Training and evaluating compounding personnel is very important. Because personnel are recognized as the primary source of contamination. The personnel need to be adequately trained especially on the aseptic technique and all the specification for facilities and devices in which they must perform. And the effectiveness of training be tested. Aseptic technique is the highest level of quality and purity of all dosage forms, compounding personnel need to know the nature of contaminants, means achieving the required level, and maintaining stability during the beyond use date
245.9
About the garb and behavior, there are several points required attentions.
252.3
Number 1: Avoid shedding of viable and nonviable particles from the body.
260.3
Number 2: Remove outer garments, all cosmetics on all hands, wrist, and other jewelry or piercing before entering the clean room.
276.5
Number 3: Natural nails must be kept neat and trimmed.
283.9
Number 4: When you wear the Personal Protective Equipment: should be done from the dirtiest to the cleanest.
296.7
Number 5: Routine application of 70% alcohol to all the surfaces throughout the compounding process and whenever nonsterile surfaces are touched.
308.3
Number 6: Avoid touching critical sites,
314.4
that is a location that include any component or fluid pathway surface or openings exposed and at risk of direct contact with air, moisture, or tough contamination.
335
About the good aseptic technique, following points need to be noticed.
342
Number 1: Be healthy, without eczema or other skin rashes, and free from allergies or other condition causing sneezing or coughing.
356.2
Number 2: Move with slow, smooth, gentle motions,avoid talking
366
Number 3: Do not interpose arms or any other nonsterile objects above a critical site in Biological Safety Cabinet, which is a vertical laminar flow air, or behind a critical site in horizontal laminar air flow.
390.8
Number 4: Do not introduce any packages into the buffer area unless they were disinfected externally.
400.9
Number 5: Minimize in and out movement at the Laminar Airflow Workbench or Biological Safety Cabinet.
413.3
Packaging and labeling on the sterile products is the last step in pharmacy. Proper labeling is an important component of safe medication system because it identifies the medication, quantity of medication, and beyond use date. Patient specific labeling should be on the product labeling, too. This could include patient name, patient’s location, time and date of administration, time and date of preparation. Verification of accuracy and sterility are two components of compounded sterile preparation. The label of final product also needs to provide storage and beyond use dating

Surface control and traffic control are two important aspects of secondary engineering controls and in this video Deputy Chiang will introduce how to control them. Personnel training is also vital, because, as Deputy Chiang says, personnel are the primary source of contamination. This video also explores some effective techniques for training personnel.

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Essentials of Good Pharmacy Practice: The Basics

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