aseptwayScope guidance · Texas sterile compounding
Decide what belongs
in the certification job.
Start with the question that changes your scope. No contact details needed.
Does moving a hood change its scope before the sticker date?
Yes. For laminar airflow hoods, Texas 291.133(d)(9)(A)(ii) requires independent operational-efficiency certification initially, at least every six months, AND on the specified relocation, alteration or major-service events. Each ISO-classified area also needs certification at least every six months AND when equipment is relocated OR buffer/anteroom structure is altered, under (d)(16)(C)(ii). A moved hood calls for review of the affected classified environment as well as the PEC. A routine sticker does not settle that scope.
Bring the move, affected room and any room alterations into your request. Aseptway will ask the provider to confirm affected testing; the PIC must resolve operational implications before resuming compounding.
Carry this into my scopeRooms, PECs and sampling are different parts of the job.
A primary engineering control (PEC) provides the ISO 5 environment for critical work. A buffer room and anteroom have their own classifications and certification scope. ISO 5, 7 and 8 are classifications, not equipment counts or CSP categories. Proposed room review includes air cleanliness, pressures and air changes per hour, with acceptance criteria in the records. Provider-confirmed PEC performance work may include HEPA integrity, airflow and smoke-pattern testing. Viable air sampling measures microbial contamination; it does not replace particle certification.
Keep device identities linked to their rooms. Name sampling already arranged so it is not duplicated. An unknown model or anteroom class can remain open while we prepare the job.
Carry this into my scopeA service visit is not the final microbial report.
Active volumetric viable air sampling in active classified areas takes place during dynamic operating conditions under (d)(16)(C)(v). Early or after-hours access alone does not establish those conditions. The incubation options under (d)(16)(C)(vi) require at least five days even when incubation is concurrent. A final microbial report requested less than five days after sampling appears incompatible with those minimums. This is an incubation screen, not a five-day report promise; processing and reporting may take longer.
Separate your preferred access from your final-report deadline. If visit and final-result targets leave too little time, Aseptway will discuss earlier sampling or a revised final-report target with the provider and PIC. We will establish the applicable protocol, reporting timeline and staff/workflow needs.
Carry this into my scopePlanning any Category 3 work changes viable air sampling timing.
Under (d)(16)(C)(v), Category 1/2 viable air sampling is at least every six months. ANY Category 3 work requires sampling within 30 days before commencement AND at least every three months thereafter, regardless of how often Category 3 work occurs. This is a sampling condition, not a universal three-month certification interval. For a January 15, 2027 start, December 20 is 26 days before and fits that timing window; December 1 is 45 days before and does not satisfy it by itself.
Give the first Category 3 date and desired final-report date. The provider and PIC must review the full program, which has requirements beyond this coordination scope.
Carry this into my scopeA hazardous unit needs its actual identity and configuration.
A chemical fume hood is not a sterile-compounding PEC. The cited nonhazardous BSC provision, (d)(9)(B)(iii)(II), must not be generalized to hazardous equipment. CAI/CACI provisions in (d)(9)(C)/(D) are conditional, not blanket placement or containment exceptions.
If the unit may be a BSC or CACI, leave that uncertainty visible. Aseptway will seek provider/PIC review of installed configuration, manufacturer documentation and applicable current requirements before recommending an isolator-specific route.
Carry this into my scopeApplicability and source
Guidance concerns Texas sterile-compounding pharmacies, including Class A-S, using the adopted 291.133 text effective March 1, 2026. Site facts, later amendments and applicable current standards must be checked before consequential advice. This is scope guidance, not a determination of compliance or permission to compound.
Texas Register adopted 291.133 textFor provider/PIC confirmation: current rules, installed configuration, applicable procedures and manufacturer requirements. Equipment certification alone does not establish facility-wide compliance.