SOP-LB-001: Sample Collection & Transport

1. Purpose

This Standard Operating Procedure (SOP) establishes standardized methods for the collection, handling, and transport of menstrual blood samples for stem cell isolation. Proper collection is critical for maintaining cell viability and ensuring reproducible results.

2. Scope

This procedure applies to all personnel involved in sample collection, processing, and transport within the Liquid Biologics research program. All samples must be collected under approved IRB protocols with appropriate informed consent.

3. Definitions

MenSCs: Menstrual blood-derived mesenchymal stem cells
Collection Device: Menstrual cup, sponge, or specialized collection container
Transport Media: Buffered solution for maintaining cell viability during transport
Chain of Custody: Documentation tracking sample from collection to processing

4. Materials & Equipment

Item	Specification	Purpose
Menstrual Cup	Medical-grade silicone, 15-30ml capacity	Primary collection device
Collection Tube	50ml conical, sterile, RNase/DNase-free	Sample container
Transport Media	PBS + 1% BSA + antibiotics	Maintain cell viability
Cooler Pack	Insulated, validated for 4-8°C	Temperature maintenance
Ice Packs	Gel refrigerant, pre-frozen	Cooling agent
Chain of Custody Form	LB-COC-001	Documentation
Biohazard Labels	UN3373 compliant	Safety marking

5. Donor Eligibility Criteria

5.1 Inclusion Criteria

Age 18-45 years
Regular menstrual cycles (24-35 days)
Willing to use menstrual cup for collection
Able to provide informed consent

5.2 Exclusion Criteria

Active infection or fever within 7 days
Antibiotic use within 14 days
Known blood-borne pathogens (HIV, Hepatitis B/C)
Current pregnancy or breastfeeding
Intrauterine device (IUD) containing hormones
Recent cervical procedure (< 3 months)

6. Collection Procedure

⚠️ Critical: All collections must be performed under approved IRB protocol with documented informed consent. Maintain strict confidentiality of donor information.

1

Pre-Collection Preparation

Verify donor eligibility and informed consent. Provide collection kit containing sterile menstrual cup, instructions, and biohazard transport container.

Timing: Optimal collection is Days 1-3 of menstruation for highest cell yield.

2

Collection Device Preparation

Donor washes hands thoroughly. Sterilize menstrual cup by boiling for 5 minutes or using provided sterilization wipes. Allow to cool completely before use.

3

Sample Collection

Donor inserts menstrual cup according to manufacturer instructions. Collection period: 4-12 hours maximum to prevent bacterial overgrowth.

Minimum Volume: 5ml required for processing. Ideal volume: 10-20ml.

4

Sample Transfer

Donor removes cup and immediately transfers contents to provided 50ml collection tube. Do not rinse cup contents. Record collection time on Chain of Custody form.

5

Initial Processing (if on-site)

If processing within 2 hours: Add transport media 1:1 ratio. If delayed processing: Refrigerate at 4°C immediately. Do not freeze.

6

Documentation

Complete Chain of Custody form with: Donor ID (de-identified), Collection date/time, Volume collected, Any observations, Donor signature.

7. Transport Procedure

ℹ️ Temperature Requirements: Maintain samples at 4-8°C during transport. Use validated temperature monitoring devices.

7.1 Packaging

Place sample tube in primary container (sealable plastic bag)
Add absorbent material sufficient for total liquid volume
Place in secondary container (insulated cooler)
Surround with pre-frozen gel packs (4°C conditioned)
Attach biohazard label and UN3373 marking

7.2 Time Limits

Condition	Maximum Time	Expected Viability
Room temperature (20-25°C)	2 hours	>90%
Refrigerated (4-8°C)	24 hours	>85%
Refrigerated with transport media	48 hours	>80%

8. Receiving & Inspection

Upon receipt at processing facility:

Verify Chain of Custody documentation is complete
Inspect packaging for damage or temperature excursions
Record receipt temperature
Note sample volume and appearance
Assign laboratory ID number
Store at 4°C if not processing immediately

9. Quality Control

Acceptance Criteria: Volume ≥5ml, no visible contamination, temperature maintained, documentation complete
Rejection Criteria: Visible bacterial growth, foul odor, temperature excursion >8°C, incomplete documentation
Documentation: Log all samples in Sample Receipt Log (Form LB-LOG-001)

10. Safety Considerations

Treat all samples as potentially infectious (Universal Precautions)
Wear appropriate PPE: gloves, lab coat, eye protection
Dispose of sharps and biohazard waste per institutional policy
Decontaminate work surfaces with 10% bleach or approved disinfectant
Report all spills and exposures per institutional protocol

11. References

Meng X, et al. (2007) Endometrial regenerative cells: A novel stem cell population. J Transl Med.
ISCT Guidelines for MSC Isolation and Characterization (2023)
FDA Guidance: Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
IATA Dangerous Goods Regulations for Biological Substances (UN3373)

Version	Date	Author	Changes
1.0	2026-02-21	Liquid Biologics	Initial release

Sample Collection & Transport