A Cleanroom, Not a Pharmacy Remodel: Project Charter for a Sterile Compounding Suite, With Six Things It Will Not Do
Student Name
American College of Education
HLTH5683: Project Management for Healthcare Administrators
Module 1 Assignment
Instructor Name
September 4, 2028
Purpose and Business Case
The composite 220-bed hospital's pharmacy prepares about 45,000 compounded sterile preparations a year, mostly intravenous admixtures, in a segregated compounding area: two laminar airflow workbenches in an unclassified room within the main pharmacy. The revised national standard for sterile compounding, which became official in November 2023, sharply limits what can be prepared in such an area, allowing only lower-risk preparations with a beyond-use date of no more than 12 hours (United States Pharmacopeia, 2022). As a result, the hospital buys ready-to-use syringes and bags for its operating rooms, labor and delivery and intensive care units from an outsourcing facility, at a cost of about $640,000 a year, and discards preparations that expire before use.
The project will build a cleanroom suite, an ISO Class 7 buffer room with an ISO Class 8 ante-room, meeting the standard's requirements for preparations with longer beyond-use dates. The stakes are clinical as well as financial. The 2012 outbreak of fungal infections traced to contaminated injectable steroids from a compounding pharmacy infected 753 patients (Malani et al., 2020), and it remains the reason sterile compounding standards are enforced as strictly as they are. The purpose of this project is not to build a room; it is to let the hospital make safe preparations that last long enough to use.
Objectives and Success Criteria
The project has four objectives. First, a cleanroom suite certified as meeting ISO Class 7 in the buffer room and ISO Class 8 in the ante-room, with pressure differentials, air changes and temperature and humidity within the standard's limits, operational by August 1, 2029. Second, environmental monitoring results within action levels for three consecutive months after opening. Third, no interruption in the hospital's ability to compound sterile preparations during construction. Fourth, completion within the approved budget of $2.04 million, with any variance above 5 percent approved in advance by the sponsor.
One benefit is stated as an expected outcome rather than a project objective, because it depends on operations after the project closes: a reduction in outsourced preparations of at least 60 percent, about $384,000 a year, in the first full year of operation. The project will hand this measure to the pharmacy's operations team at closeout, together with the baseline, so that the business case can be tested after the project team has disbanded.
Scope
In scope: design of the cleanroom suite within the existing pharmacy footprint, including relocation of two interior walls; construction of the buffer room and ante-room with cleanable surfaces, pass-through and hand-washing station; a dedicated heating, ventilation and air conditioning system with high-efficiency particulate air filtration and continuous pressure monitoring; purchase and installation of two primary engineering controls; initial certification and environmental sampling; written procedures for garbing, cleaning and environmental monitoring in the new suite; training and competency assessment of the 18 pharmacists and technicians who compound; and a temporary modular cleanroom to maintain compounding during construction.
The deliverables are the certified suite, the procedures, the training records and a handover package for pharmacy operations. The project ends when the suite has completed three months of acceptable environmental monitoring and the handover has been accepted by the director of pharmacy.
Exclusions
Six pieces of related work are explicitly out of scope. First, the hazardous drug compounding room, which was rebuilt in 2025 to meet the separate hazardous drug standard and is already compliant; the project will not alter it except to protect it during construction. Second, intravenous workflow management software, which pharmacy leaders want but which is a separate information technology project with its own funding request. Third, automated compounding equipment; the business case does not depend on it and its evaluation would delay the schedule. Fourth, the operating room satellite pharmacy, which does not compound and has different needs. Fifth, changes to pharmacy staffing levels; the project assumes current staff will compound in the new suite. Sixth, renegotiation of the outsourcing contract, which procurement will handle once the suite's capacity is known.
Each exclusion was discussed with the stakeholder most likely to want it included, and each has a named home: the information technology project request, the capital committee's equipment list or procurement's contract calendar. A scope that says only what is included invites every related wish to join it; the exclusions are what keep the project finishable.
Milestones and Budget
Major milestones are: charter approval, September 15, 2028; design complete, December 15, 2028; building permit, January 31, 2029; temporary cleanroom operational, February 15, 2029; construction complete, June 15, 2029; certification passed, July 15, 2029; suite in use, August 1, 2029; three months of acceptable monitoring and project closeout, October 31, 2029. The budget of $2.04 million comprises construction, $1.25 million; heating, ventilation and air conditioning, $320,000; primary engineering controls, $180,000; certification and initial sampling, $40,000; temporary modular cleanroom rental, $90,000; and contingency of about $157,000, 10 percent of construction and air handling, the two lines most likely to vary.
High-Level Risks
The charter records the risks known at the start, so that the sponsor approves the project with them in view; the full risk register will be developed later. The largest is that the new suite fails initial certification because of air balance or pressure problems, which would delay opening by weeks and extend the rental of the temporary cleanroom at about $15,000 a month. The second is that construction dust or vibration disrupts compounding in the temporary room or the existing hazardous drug room, which sits on the other side of one of the walls being moved. The third is that the lead time for the air handling unit, currently quoted at 14 weeks, grows, pushing construction past the June milestone. The fourth is that pharmacy staff, who must train in new procedures while working in a temporary space, fall behind on competency assessments before opening. Each will be assigned an owner in the risk register, and the charter sets aside the contingency described above mainly for the first and third.
Roles, Authority, Assumptions and Constraints
The sponsor is the chief pharmacy officer, who secured the capital funds and will approve changes to scope, schedule beyond two weeks and budget beyond 5 percent. The project manager, from the facilities project management office, has authority to direct the design firm and contractor, approve expenditures within the budget and schedule meetings of the project team. The pharmacy's designated person for sterile compounding owns the procedures and training deliverables. The Project Management Institute (2021) describes the charter as the document that formally authorizes a project and gives the project manager authority to apply organizational resources, and this charter is intended to do exactly that.
The charter assumes that the existing pharmacy footprint can accommodate the suite without moving the pharmacy, which the design firm's preliminary survey supports, and that the temporary modular cleanroom can be certified within two weeks of delivery. Its main constraint is that the hospital cannot stop compounding for even one day, which governs the sequence of every construction phase.
References
Malani, A. N., Kauffman, C. A., Latham, R., Peglow, S., Ledtke, C. S., Kerkering, T. M., Kaufman, D. H., Triplett, P. F., Wright, P. W., Bloch, K. C., McCotter, O., Toda, M., Jackson, B. R., Pappas, P. G., & Chiller, T. M. (2020). Long-term outcomes of patients with fungal infections associated with contaminated methylprednisolone injections. Open Forum Infectious Diseases, 7(6), Article ofaa164. https://doi.org/10.1093/ofid/ofaa164
Project Management Institute. (2021). A guide to the project management body of knowledge (PMBOK guide) (7th ed.). Project Management Institute.
United States Pharmacopeia. (2022). General chapter <797> pharmaceutical compounding: Sterile preparations. United States Pharmacopeial Convention.
How this HLTH 5683 Module 1 example is structured
HLTH 5683 Module 1 often produces a charter with scope drawn around what is excluded too; your classroom's instructions decide the charter template. This example follows the common charter structure: purpose and business case, objectives and success criteria, scope in and out, milestones, budget, roles and authority, assumptions and constraints. The exclusions section explains why each item is out, because an exclusion without a reason is the first thing a stakeholder will try to reopen.
HLTH5683 Module 1 questions, answered
What does HLTH5683 Module 1 usually ask for?
HLTH5683 Module 1 often asks students to write a project charter for a health care project, typically including purpose, objectives, scope, exclusions, milestones, budget and roles. Many sections emphasize defining what is out of scope as clearly as what is in. Your classroom's instructions decide the template.
Why list exclusions in a project charter?
Exclusions prevent scope creep by stating which related work the project will not do. Giving each exclusion a reason and naming where that work belongs makes it harder for stakeholders to reopen the boundary later.
What authority should a charter give the project manager?
The charter should state what the project manager can decide alone, such as directing contractors and approving spending within budget, and what requires the sponsor, such as changes in scope or budget beyond a set threshold.
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