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§ Quality & testing · Independent laboratory data

Quality & testing.

Every F-head fastener is built to be measured. Two independent third-party studies — ASTM B117 salt-spray corrosion and a quantitative Bacillus subtilis disinfection trial — documenting how F-head performs against conventional hardware.

§ Study 01 · Microbiology

Evaluation of residual Bacillus subtilis on different fastener types after disinfection.

Deanna L. Kiska1, Rebecca A. Moran1, Jeff Serle2, and Chris Lee3
1U.S. Micro-Solutions, Inc., Latrobe, PA  ·  2Flush Fasteners®, Daytona Beach, FL  ·  3EpiClear Consulting, Columbus, OH
§ 01

Introduction

Fasteners are used in critical environments for assembly of equipment or for attachment of switch plates or wall devices. These fasteners are available in a variety of head configurations. All head configurations include some type of recessed cavity to accommodate various drivers which secure them in place. These cavities can be difficult to clean and may harbor microbiological contaminants.

A current solution to this issue includes filling the fastener cavity with silicone. This is not ideal since the silicone can be mechanically disrupted during cleaning, potentially creating an environment that harbors contamination.

A fastener with a flush head would facilitate cleaning and could potentially decrease or eliminate microbiological contamination. The F-head fastener (Flush Fasteners®), manufactured from type 316 L stainless steel, is designed with an automated plunger that seamlessly reverts to a flush position after the tool is removed, with a clearance of less than 6 microns.

This study sought to compare F-head fasteners (flush) and conventional slotted fasteners to determine the level of residual Bacillus subtilis after fastener inoculation and disinfection.

§ 02

Methods

Fasteners (flush and slotted) and stainless-steel plates containing four bolt holes were sterilized by autoclaving. The fasteners were aseptically inserted into the bolt holes. Each steel plate contained 2 flush fasteners (A) and 2 slotted fasteners (B) (Fig. 1). A total of 32 samples of each fastener were tested.

An inoculum of Bacillus subtilis subsp. spizizenii ATCC 6633 (ReadyNow™, Stratix Labs) was prepared in sterile phosphate buffered saline to achieve 105 CFU/mL. The central area of each fastener was inoculated with 10 µl (103.6 CFU) of the prepared B. subtilis suspension. The inoculum was allowed to dry for ~30 minutes.

Fig. 1Example of steel plate and fastener set-up. A = flush fastener, B = slotted fastener.

Dry lint-free sterile wipes were saturated with Peridox RTU (PREempt Plus, Contec). A separate wipe was used to clean each fastener, moving unidirectionally away from the center of the steel plate. The fastener surfaces were continually wiped as needed to allow 3 minutes of wet contact time.

After 3 minutes, a sterile 70% isopropyl alcohol (IPA) wipe was used to wipe each fastener and the surfaces were allowed to dry. The fasteners were aseptically removed from the steel plate to 1 ml of HiCap™ neutralizing broth (World Bioproducts) and eluted for 1 minute. The broth was vortexed and then plated in duplicate to tryptic soy agar (TSA). The agar plates were incubated at 35±2°C for 18–20 hours and colony counts were determined.

In the lab.

Six-step protocol · n = 32
§ 01 — Inoculate

Inoculation of fasteners with 10 µl of the subtilis suspension.

§ 02 — Dry

Post-inoculation, the solution was allowed to dry for 30 minutes.

§ 03 — Disinfect

Samples cleaned post-inoculation with lint-free sterile wipes saturated with Peridox RTU.

§ 04 — Elute

Samples placed in HiCap neutralizing broth and eluted for 1 minute.

§ 05 — Plate

Broth placed in agar plates to be incubated.

§ 06 — Count

Post 18-hour incubation, samples were analyzed and colony count values were taken.

§ 03

Results

Thirty-two samples of each fastener type were analyzed, each sample being plated in duplicate to yield 64 colony count values for each fastener (Table 1, Fig. 2).

Table 1 Fastener colony count values.
Fastener type # Samples Avg. count Median High Low
Flush 32 3.17 2 18 0
Slotted 32 172.64 162 549 0

A paired t-test was chosen to statistically assess the difference in residual Bacillus subtilis remaining on the two fastener types post-disinfection. Since the fastener pair duplicates were processed on the same steel plate, the sample pair duplicates cannot be considered truly independent from one another. Therefore, two different paired t-tests were conducted, each including one sample pair from the 32 sample groups.

Sample group 1 encompassed all odd-numbered pairs and sample group 2 all even-numbered pairs (Table 2).

Fig. 2 B. subtilis colony count remaining on fasteners post-disinfection
0 50 100 150 200
3.17
172.64
Mean colony count Flush Slotted
Fig. 2B. subtilis colony count remaining on fasteners post-disinfection.
Table 2 Statistical analysis of fastener colony counts.
Sample group # Samples Mean (flush) Mean (slotted) p value
1323.16177.663.05 × 10⁻⁹
2323.19167.632.83 × 10⁻¹⁰
Both paired t-tests yielded p < 0.00001 — residual B. subtilis on flush fasteners was significantly less than on slotted fasteners in both sample groups.
§ 04 — Conclusion
>98%

Post-disinfection colony count lower on flush fasteners
than on standard slotted fasteners.

3.17 vs. 172.64 mean colonies · p < 0.00001
§ Study 02 · Corrosion

Salt-spray resistance. 168 hours in a 5% NaCl atmosphere, per ASTM B117.

Metallurgical Engineering Services, Inc. · Daniel A. Stolk, PE, CWI — Principal Engineer
Firm Registration No. F-2674 · Richardson, TX  ·  Lab No. 48978 (Rev. 1, 11/11/2024)
Testing: 10/29/2024 – 11/05/2024 · Reported: November 6, 2024
§ 02 · Procedure

Accelerated corrosion

Four F-head fasteners (lab-identified as samples 1–4) were submitted for salt-spray corrosion testing per ASTM B117, the standard practice for operating salt-spray (fog) apparatus.

Testing was performed using a Singleton 031M-066 environmental chamber (S/N 42-274-011, calibration due 03/01/2025). Distilled water was used in preparing the 5% salt solution. Temperature was recorded twice daily; salt-solution collection rate, specific gravity, and pH were measured continuously through the 168-hour exposure.

Salt spray test samples, as received — Lab No. 48978
Fig. 1Four F-head fasteners (samples 1–4) as received by the lab — photo documentation per ASTM B117 incoming protocol.
Duration
168hours
Solution
5%NaCl
Chamber temp
97°F avg
pH
7.05
Specific gravity
1.037

Results at 168 hours

Each sample photographed before and after 168 hours of continuous salt-fog exposure:

0 hr
168 hr
Sample 01
0% rust
✓ No red rust
No red rust product observed on sample surface.
0 hr
168 hr
Sample 02
5% surface
Localized red rust
Red rust observed on 5% of sample surface.
0 hr
168 hr
Sample 03
0% rust
✓ No red rust
No red rust product observed on sample surface.
0 hr
168 hr
Sample 04
10% surface
Localized red rust
Red rust observed on 10% of sample surface.
All four fasteners maintained full functionality after 168 hours of continuous salt-spray exposure.
— Per the test report dated November 6, 2024 (Rev. 1, 11/11/2024)
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