🧤 GFT & Surface Sample Generator — Precision Pharma

Auto-populates incubator data, temperatures, plate lots from tracker · Print pre-populated form

1 Test Details

2 Auto-Populated from Tracker

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3 Surface Sample Locations

Enter the location description for each sample. These print on the form. Leave blank if not used.

4 Generate Form

PRECISION PHARMA

555 Heritage Drive, Lab 143 • Jupiter, FL 33458
Tel: 561-941-3900 • orders@precisionpharma.org
USP <797> Category 3 • §503A • FL: PH35541, PH35823

GLOVED FINGERTIP & SURFACE SAMPLE LOG

SOP: EM-GFT-SS-001 • USP <797> Cat 3

GFT Action Level: 0 CFU/hand • SS: per USP Cat 3 ISO class

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1. BATCH & PERSONNEL IDENTIFICATION
BCR Lot #— Test Date—
Personnel Name— Qualification Status
Supervisor / Observer— Test Session #
2. GARBING & GOWNING
Garbing Location Time Entered Cleanroom
Gowning Checklist — tick each item
☐ Coverall ☐ Hood ☐ Face mask ☐ Goggles ☐ Boot covers ☐ Sterile gloves ×2
3. INCUBATOR SETUP — Auto-populated from Equipment Register & EM Daily Temp
IncubatorID Temp Set (°C)Last Cal Date Recent Actual (°C)Cal StatusTech ✓
Verify incubator temperatures are within range before placing plates. INC-001 target 30-35°C (first 48h). INC-002 target 20-25°C (days 3-7).
4. GLOVED FINGERTIP TEST (GFT) — Action Level: 0 CFU per hand
Press each of the 5 fingers firmly onto agar for 5 seconds. Do not rotate. Label plates immediately with plate ID and time.
PlatePlate ID / Lot # Cat #Media Type ExpiryTime InTech ✓
Incubator ID— Temp Set (°C)—
Date Plates In Time In
Tech Initials Supervisor Initials
5. SURFACE SAMPLES (SS) — Action Levels: ISO 5 = 1 CFU • ISO 7 = 10 CFU • ISO 8 = 100 CFU
Place agar plate face-down on surface for 5 seconds. Do not press or slide. Label immediately.
# Sample ID Location Description ISO Class Plate Lot # Cat # Expiry Tech ✓
Incubator ID— Temp Set (°C)—
Date Plates InTime In
Tech InitialsSupervisor Initials
BCR Lot #: — PRECISION PHARMA — CONFIDENTIAL — Retain 4 years Date: — Page 1 of 2

PRECISION PHARMA

555 Heritage Drive, Lab 143 • Jupiter, FL 33458

GFT & SURFACE SAMPLE LOG — PAGE 2

BCR Lot #: —

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6. 7-DAY INCUBATION RECORD — Check all plates daily. Record date, temp, CFU count per plate.
INC-001 (30-35°C): Days 1-2. INC-002 (20-25°C): Days 3-7. Record actual incubator temp at each daily check. Count CFU under magnification if needed.
Plate Day 1
Date		CFU Day 2
Date		CFU Day 3
Date		CFU Day 4
Date		CFU Day 5
Date		CFU Day 6
Date		CFU Day 7
Date		CFU Total CFU
7. RESULTS SUMMARY
Test Total CFU Action Level Exceeds? Y/N Pass / Fail Reviewed By / Date
8. CORRECTIVE ACTION (complete only if any result exceeds action level)
Deviation Form Ref #
Action Taken
Follow-up Required Y/NResolved By / Date
9. SIGN-OFF
Compounding Technician
Name: —
Date: _______________ Time: _______
Supervisor / Observer
Name: —
Date: _______________ Time: _______
Director of Compliance (Review)
Marcia Walker, PharmD
Date: _______________ Time: _______
Retain minimum 4 years per Florida BoP & USP <797>. Alterations: single-line strikethrough + initials + date. No correction fluid.
BCR Lot #: — PRECISION PHARMA — CONFIDENTIAL — Retain 4 years • SOP: EM-GFT-SS-001 Date: — Page 2 of 2
Form Ready — —