Introduction: 

Training workshops are an effective and practical way to introduce personnel to aseptic processing concepts for the first time. The workshop integrates newly acquired didactic compounding knowledge into a multi-sensory, reality-based, “tell me-show me-let me do it” immersive learning experience. In this intimate environment, the “coach” exposes the participant to a gamut of manipulative techniques necessary to build the dexterity and skill set needed to begin compounding. The coach is also in an ideal position to determine the natural ability of each participant, adjust training periods, and “release to compound” timing considerations.

USP <797> Sec.2.1 (see Figure 1) does not prescribe the way personnel become “competent enough” to compound for human use. It is up to the facility to determine the training method utilized to build a knowledge and skills base that ensures the safety of compounded sterile preparations (CSPs) This brief article stresses the utility of workshops to address different aspects of staff training and education for initial competency requirements and the ongoing readiness of existing staff. It serves as an immersive experience to achieve the sensitivity needed for highly technical work.

2.1 Demonstrating Proficiency in Core Competencies

Before beginning to prepare CSPs independently, all compounding personnel must complete training and be able to demsonstrate knowledge of principles and proficiency of skills for performing sterile manipulations and achieveing and maintaining appropriate environmantal conditions.

Competency must be demonstrated every 6 months in at least the following:

• Hand Hygiene
• Garbing
• Gloving
• Aseptic Technique
• Media Fill Challenge

And every 12 months in at least the following:

• Cleaning and disinfection
• Calculations, measuring, and mixing
• Achieving and/or maintaining sterility and apyrogenicity
• Use of equipment
• Documentation of the compounding process ( e.g., master formulation and compounding records)
• Principles of high-efficiency particulate air (HEPA)-filtered unidirectional airflow within the ISO Class 5 area
• Proper Use of primary engineering controls(PECs)
• Principles of movement of materials and personnel within the compounding area

Figure 1

Who Should Train

Candidates will include those truly interested in sterile compounding, those seeking a career ladder promotion, or both. Because sterile compounding requires a specific skill set and specific psycho-motor skills, it is recommended that candidates can physically and mentally fulfill all the requirements.

Workshop Types and Uses

1. Introduction to sterile compounding: This is to train non-compounders as part of the “initial” validation and apprenticeship program.
2. Abbreviated Workshops (30 – 60 min): These are specific skills or refreshers of aseptic techniques related to a particular aspect of workflow (elastomeric pump fill, volumetric pump calibration, etc.). They can be done inside the department by setting up a table with information (SOP, policy, or manufacturer’s instructions, for example).
3. Special circumstances remediation workshops (30 min): These are helpful after a regulator’s finding, policy or SOP change management, new compounding equipment, etc. This type can be used as evidence of staff education for submittal to the pharmacy board, the Joint Commission, or others.
4. Train the trainer(s): Opportunities for tech development to become aseptic technique validators and/or the development of a technician designated person to work in tandem with pharmacy leadership on all aspects of sterile compounding operations.

Design and Educational Expectations of an Introductory Compounding Workshop

Location: A conference or classroom setting is usually acceptable. Note: DO NOT attempt to train newbies within a classified space.

Room Configuration: Use the furniture in the conference room (partitions, tables, etc.) to create a simulated IV room (pretend Ante, Buffer, Sink, etc.). Signage such as “ANTE,” “BUFFER,” and “SINK” can help create a more effective simulated environment.

Length: 4 to 8 hours

Number of Participants

The recommended maximum enrollment capacity is one coach for every five participants. Training, providing follow-up, and validating more than five participants at a time will be difficult. They must all be apprentices for several weeks before being released to solo work.

Skills Emphasis

USP 797 or 800. Incorporating both in the same venue is not recommended since aseptic HD compounding is considered an advanced skill.

What to Cover

Determine your most critical and essential set of skills in which to build other more advanced skills.

Materials

Syringes, needles, vial spikes, bag dispensing pins, other compounding aides and devices, and simulation meds.

Equipment

Video equipment will be used to record sessions if applicable.

Cost Considerations

Estimate the cost of IV supplies per day for each event (4-5 participants). Include educational resources in your annual IV operational budget.

Suggested Workshop Design:

08:00 – 08:15 am Attendance and Agenda

08:15 – 09:00 am Hand Hygiene, Garbing, Gloving (3 times)

09:00 – 10:00 am Proper Use of Laminar flow hood zones and first aid principles

10:00 -10:15 am Break

10:15 – 12:00 am Aseptic Techniques Principles Workshop (Part 1)

12:00 – 1:00 pm Lunch

01:00 – 4:00 pm Aseptic Techniques Principles Workshop (Part 2)

04:00 – 04:30 pm Assessments orientation, wrap up, adjournment

Content:

The workshop should clearly explain the risks, and sequence necessary to execute manipulative aseptic techniques. For each of the below mentioned processes, the coach must explain best practices, proper syringe holds and how a particular compounding process affects hand and critical site exposure to first air. The following processes are suggested as basic skills.

• • Reconstitution, withdrawal, and transfer to a final container bag (IVPB and LVP)
  • Compounding Stock solutions
  • Making syringes from source bags or stock solutions
  • Ampule break, solution withdrawal, and filtration technique
  • Gravity transfers using a transfer set

Beware of Training Without Adequate Practice Time

Training can fail to have its full impact when participants cannot practice their skills during compounding next to an experienced peer. The number of live compound hours will depend on the trainee’s skill level but should usually span about 2-3 weeks. Inadequate practice time frustrates efforts to advance personnel to a new job role and creates morale problems.

Participation and Documentation

1. 1. Documenting as education- ” I trained my staff.” Using your facility’s approved assessment forms.
   2. Documenting as a corrective or remedial action – “I addressed regulatory or compliance concerns.” Using a remedial form such as a CAPA (Corrective Action and Preventive Action) form as per facility guidelines. Do check with your HR department as to a CAPA related to a performance breach should be utilized for personnel evaluation purposes.
   3. Documenting as an internal HR management tool- “I addressed the performance issue.”

Conclusion

USP 797 does not prescribe the educational methodology for introducing new personnel to sterile compounding. A workshop is an immersive and interactive way to integrate didactic training and practical skills. It must contain all the basic skills needed to perform simple compounding operations. All training must always be followed up with opportunities for live compounding supervised by an experienced compounder prior to release to work.  For assistance designing or hosting a sterile compounding workshop, contact Seven97 Training Solutions by email: luis.hernandez@my797trainer.com, filling a contact form at the following webpage www.seven97training.com, or call (305) 972-2595.

Released February 2025

About the Author

Luis Hernandez, RPh, BCSCP, is a certified sterile compounding pharmacist and the founder of Seven97 Training Solutions. Dedicated to advancing USP 797 pharmaceutical training, validation, and certification, Luis aims to promote and inspire excellence in aseptic processing, medication and patient safety, and regulatory compliance.

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