TICKERWORKS Troche & Suppository Mold Cleaning Guide

How to clean, sanitize, dry, store and inspect silicone and TPE troche molds, lozenge molds, rapid-dissolve tablet (RDT) molds and suppository molds (moulds) used in compounding pharmacies, with USP <795> and USP <800> guidance. For TICKERWORKS Teflon-free (PTFE-free) compounding molds.

Revision 2.1 — October 16, 2026 · Original cleaning validation protocol: August 2018 · Questions: support@tickerworks.com

Download the full guide (PDF) Do's & Don'ts quick card (PDF)

Important notice

This guide is for educational and informational purposes only. It is not a validated procedure for any specific compound and is not legal, regulatory or professional advice.

It draws on TICKERWORKS product knowledge, published references and limited internal TICKERWORKS observations. TICKERWORKS makes no guarantee or warranty of cleaning, deactivation or decontamination results for any compound, API or hazardous drug.

Each pharmacy is solely responsible for developing, validating (including any required third-party analytical testing) and documenting its own procedures under its state board of pharmacy, USP <795>/<800> and other applicable requirements. Use is at the user's own risk. See Section 20 for the full disclaimer.

Protect the compounding mold surface

The very smooth, Teflon-free cavities release doses cleanly and clean easily. Scratches trap residue and cause sticking, and cavity damage cannot be polished out. This rule applies to every section of this guide.

• Use: soft nylon or silicone brushes, microfiber or soft lint-free cloths, approved soft swabs, gloved fingertips.
• Do not use: scouring pads, steel wool, stiff brushes, metal or sharp tools, abrasive powders or creams, or baking-soda paste.
• Keep flat: dry and store compounding molds flat. Avoid bending, folding, or stacking them under weight.

1. Purpose

This guide describes how to clean, dry, store, inspect and retire TICKERWORKS compounding molds (silicone and TPE). The goal is to remove residue consistently between uses, whether it comes from water-soluble polyethylene glycol (PEG) bases, fatty-acid/lipid bases such as progesterone in medium-chain triglyceride (MCT) oil, or gelatin, glycerin and RDT bases.

TICKERWORKS compounding molds are flexible, so finished doses release when the mold is flexed. They are Teflon-free silicone or TPE, unlike rigid metal molds, which are often Teflon-coated and harder to demold. Silicone molds are cast from highly electropolished stainless-steel masters, so the cavities are very smooth and resist particle adhesion. Preserving that finish is a central goal of this procedure.

Consistent, non-abrasive cleaning helps prevent cross-contamination and carry-over, preserves release performance, and supports the pharmacy's documentation obligations under USP <795> (Pharmaceutical Compounding—Nonsterile Preparations).

Basis of recommendations: water temperatures, IPA contact times, deep-clean intervals and the heat reset reflect TICKERWORKS product knowledge, published references and limited internal observations. They have not been validated for any specific compound, API or base.

2. Scope

This guide covers all TICKERWORKS silicone and TPE compounding molds used for nonsterile compounding.

• Bases covered: residue from commercial bases supplied by compounding suppliers such as PCCA, SpecializedRx, Medisca and Fagron, described generically as (a) PEG-type water-soluble bases, (b) fatty-acid/lipid bases, and (c) gelatin, glycerin and RDT bases. Proprietary compositions are not described; consult the base supplier's product information and SDS.
• Activities covered: routine and deep cleaning, dishwasher use, heat reset (silicone only), drying and storage, inspection, retirement, hazardous-drug considerations, troubleshooting and record-keeping.
• Not covered: sterile compounding; cleaning of the compounding area or primary engineering controls; HD deactivation and decontamination chemistry, which the pharmacy's own SOPs govern (USP <795>, <797>, <800>). TROCHE POPS, CHEW POPS and RDT POPS pods are single-use and are not cleaned or reused.

2.1 Identify your compounding mold

Several steps differ by material. Heat reset and baking are for silicone only and will damage a TPE mold. Confirm the material before following Sections 8–10.

Identify the mold by cavity size and count, not color. Some silicone and TPE molds share a color (for example, the teal silicone 0.5 mL x 120 and the teal TPE Pebble Beach 0.5 mL x 100 Mini).

For any TICKERWORKS mold not listed here, check its product page and specification sheet at TICKERWORKS.COM. Not sure which material you have? Contact support@tickerworks.com before any heat reset.

3. Responsibilities

• Compounding personnel: clean and document per this guide and the pharmacy's SOP; protect the mold surface; report scratched, deformed or damaged molds.
• Compounding pharmacist, head technician or team leader: approves the pharmacy's adopted procedure; ensures training and competency (USP <795>: initially and at least every 12 months); reviews logs; decides on continued use after heat resets or questionable damage (Sections 10, 12).
• TICKERWORKS: provides product information and support at support@tickerworks.com and publishes the current guide at TICKERWORKS.com/pages/troche-suppository-mold-cleaning-guide.

4. Materials and Key Technical Notes

4.1 Silicone compounding mold material

4.3 Why oily residue is persistent

Silicone is non-polar and slightly permeable to oils. MCT oil, fatty-acid bases and lipophilic actives can partially absorb into silicone and later return as a greasy film, odor or tackiness. Detergent and alcohol remove surface oil; the heat reset (Section 10, silicone only) drives absorbed oil back to the surface for washing. PEG bases are water-soluble and generally dissolve in warm water. Gelatin bases dissolve in warm water but can set onto surfaces if very hot water is applied first.

4.4 Heat limits and oven warnings

• Silicone: maximum 302°F (150°C) continuous use. The heat reset (270–280°F) is close to this limit, so use an independent oven thermometer and do not exceed 280°F.
• TPE: maximum 250°F (121°C) continuous use. Do not heat reset or bake TPE molds (Section 17).
• Do not use a microwave or hybrid microwave/convection oven for any TICKERWORKS compounding mold. Microwave energy and convection hot spots can heat the material unevenly above the set temperature.
• Use only a dedicated, ventilated equipment oven reserved for compounding equipment and never used for food (see also Section 15).

4.5 Isopropyl alcohol (IPA)

• Silicone and TPE tolerate 70–90% IPA for short contact. IPA can cause slight, temporary swelling that reverses once it evaporates; long soaks may extract low-molecular-weight components.
• 70% IPA is the preferred sanitizer; the water content makes it more effective than 90%.
• Limit wet contact time to 5–10 minutes, by immersion or by re-wetting a cloth so surfaces stay wet. Do not store molds in IPA. Let IPA evaporate completely before rinsing, reuse or heating.
• IPA is flammable. Do not place a mold in an oven until all IPA has evaporated and the mold has been rinsed with water and dried.

4.6 Approved and not-recommended cleaning agents

• Dissolve detergent powders (including Alconox) completely before use; do not apply powder directly to cavities.
• Dishwasher detergent note: standard dishwasher detergents are mildly alkaline. In TICKERWORKS experience they are acceptable for silicone and TPE molds at normal cycle use. Avoid commercial or "heavy-duty" caustic formulas, and always finish with a purified-water rinse (Section 8.5).
• Release sprays, oils and "seasoning" add uncontrolled excipients to the preparation and leave films that trap residue.

4.7 Vinegar (acetic acid): restricted use

Published chemical-resistance data for cured silicone generally rate dilute (5%) acetic acid and vinegar as excellent at room temperature (GE Silicones; Bostik; Parker). The data are not unanimous (Adpol rates vinegar "doubtful"), hot acetic acid is rated doubtful to unsatisfactory, and the silicone SDS cautions against strong acids. Vinegar also does little to remove triglyceride oils.

Vinegar is not part of the standard routine. Occasional use at a deep clean, for hard-water haze or odor, is acceptable only under all of these conditions:

• household distilled white vinegar (\~5%) or weaker, at room temperature only (never hot, and never combined with the heat reset);
• contact of 10 minutes or less, with fresh vinegar each time;
• a glass or polypropylene tray, not metal;
• never mixed with baking soda, and rinsed off thoroughly before any baking-soda step;
• a thorough hot-water rinse, a purified-water final rinse, and complete drying before any heat reset.

These restrictions apply to silicone and TPE molds.

4.8 USP <795> expectations

• Compounding molds are nondisposable equipment. USP <795> (official November 1, 2023) requires equipment to be cleaned (and sanitized as applicable) before first use and thereafter per the manufacturer's recommendations, or if none, between CNSPs with different components. This guide is the TICKERWORKS manufacturer recommendation.
• Cleaning must precede sanitizing. 70% IPA is an appropriate equipment sanitizer. Use purified, distilled or RO water for the final rinse.
• Document cleaning on days when compounding occurs. Keep records readily retrievable for at least 3 years, or longer per state law.
• Personnel performing cleaning must demonstrate competency initially and at least every 12 months.

4.9 Drug and excipient compatibility

As with any compounding mold material, including metal molds, some drugs and excipients may not be compatible with silicone or TPE molds. The pharmacist is responsible for researching the compatibility of each API, base and excipient with the mold material before use.

• Excipients and flavorings: use concentrated flavoring oils, essential oils, terpenes (e.g., d-limonene, menthol) and strong solvents with caution. They can swell the mold material, linger as odor, or affect release.
• Diclofenac: identified as a potential incompatibility with TPE molds. As a precaution, TICKERWORKS recommends using silicone molds, not TPE molds, for diclofenac preparations.
• When in doubt, verify with cleaning and carry-over testing (Section 16) and contact support@tickerworks.com.

5. Equipment, Tools and PPE

5.1 Approved and not-recommended tools

• Swabs: for stubborn residue in deep cavities, corners and embossed lettering, use approved swabs with about 5 light rotations per cavity. Start a fresh swab for each row, or sooner if soiled.
• Replace brushes when bristles splay or harden.
• Demold by flexing the mold. Do not pry doses out with tools.

5.2 Equipment, materials and PPE

6. Base-Specific Cleaning Guidance

Identify the base in the preparation just compounded and follow the matching path. Check the base supplier's product literature and SDS.

Definition of a use: one use = one fill, set and demold of the compounding mold. Two batches poured into the same mold on the same day count as two uses.

Deep clean sooner whenever a film appears. When switching base types, or between preparations with different components, always perform the full fatty-base routine clean, including IPA, before the next use.

7. Before First Use

1. Remove the mold from its packaging. On its record card (Appendix A), record the pharmacy-assigned ID, purchase date and first-use date (this starts the service-life clock, Section 13.1), plus product code and lot number if present.
2. Confirm the material (silicone or TPE) using Section 2.1 and record it.
3. Inspect for defects (scratches, tears, inclusions, odor, tackiness, deformation) with a 3x magnifier.
4. Perform a full clean per Section 8, including IPA and a purified-water final rinse. No bake, seasoning or conditioning step is needed or recommended.
5. Dry flat (Section 11) and log the cleaning before placing the mold into service.

8. Routine Cleaning (After Every Use)

Clean as soon as practical after doses are removed, and always before the mold is used for a preparation with different components. If the preparation contained a hazardous drug, follow Section 15 first.

8.1 Pre-clean

1. Put on PPE. Demold by flexing the mold.
2. Lift out loose fragments with gloved fingertips. Blot (do not scrape) bulk residue with a soft, lint-free wipe. Dispose of wipes per the pharmacy's waste procedures.

8.2 Detergent wash by hand (or use the dishwasher, Section 8.5)

1. Prepare a fresh, fully dissolved approved detergent solution in very hot water, \~140–160°F (60–71°C). Use warm water for PEG-only residue, and a warm pre-soak for gelatin or RDT residue (Section 6).
2. Immerse the mold and clean every cavity, rim and the underside with gloved fingertips, microfiber or a soft brush, using light pressure. Repeat the wash rather than scrubbing harder.
3. For stubborn residue in deep cavities, corners or embossed lettering, fill the cavities with hot detergent solution and work each with an approved swab: push gently to the bottom and make about 5 rotations. Use a fresh swab for each row.
4. Rinse with hot running water for about 1 minute, until no detergent film remains. If residue is still visible, repeat the swab step.

8.3 Alcohol degrease / sanitize

1. Fatty/lipid or mixed bases: keep all surfaces wet with 70% IPA for 5–10 minutes, by immersion or by repeatedly re-wetting with a soaked lint-free cloth.
2. PEG, gelatin or RDT bases: a thorough 70% IPA wipe as a sanitizer is sufficient.
3. Let surface IPA flash off in a ventilated area.

8.4 Final rinse and dry

1. Rinse with hot water, then give a final rinse with purified, distilled or RO water.
2. Shake off excess water gently. Dry face down or flat on a stainless-steel grid that supports the whole mold (Section 11) until completely dry with no alcohol odor. Blot if needed; do not rub cavities.
3. Inspect (Section 12) and record the cleaning in the log.

Acceptance check after routine cleaning: visually clean under good lighting; no greasy or tacky feel to a gloved fingertip; no water beading in oily patches; no odor of base or alcohol; no new scratches; lies flat; fully dry.

8.5 Dishwasher

TICKERWORKS silicone and TPE molds are dishwasher safe, and TICKERWORKS recommends the dishwasher as an efficient, consistent alternative to hand washing.

Loading rule: place each mold face down and completely flat on the rack. Do not load a mold bent, curled, folded, propped against tines or wedged between items. Hot water softens the material, and a mold washed out of shape can permanently deform its cavities. If a mold does not fit flat, wash it by hand. The Pebble Beach Removal and Washer Support Rack can support molds during washing.

1. Complete the pre-clean (8.1). Pre-treat stubborn spots with swabs if needed.
2. Load each mold face down and flat, away from the heating element, with no sharp utensils or metal items touching it.
3. Use a dishwasher or laboratory glassware washer used only for compounding equipment, with standard non-chlorinated detergent (Section 4.6). For TPE molds, keep cycle temperatures at or below 250°F; normal dishwasher cycles are well below this.
4. After the cycle, a technician inspects each mold under good lighting for residue, film, tackiness, odor, scratches and damage (Section 12). Re-wash or swab any that are not clean.
5. Confirm each mold is still flat and face down. Unload it without bending and check it on a flat surface for warping. If it was found bent, record this, let it rest flat at room temperature and re-inspect; retire it if deformation persists.
6. For fatty/lipid bases, perform the IPA step (8.3). For all bases, perform the purified-water final rinse and dry flat (8.4).
7. Record "W" in the log with the inspecting technician's initials.

9. Deep Cleaning (Periodic)

Frequency: every 5 uses for fatty/lipid, gelatin/RDT and mixed or unknown bases; up to every 7 uses for PEG-only use; and sooner whenever a film appears, routine cleaning fails the acceptance check, or after extended storage.

1. Complete the full routine cleaning procedure (Section 8).
2. Soak for 30 minutes in a fresh, hot approved detergent solution so residue softens, then clean with gloved fingertips, a soft brush or approved swabs. Extended soaking, not extra scrubbing force, is the deep-clean tool.
3. Repeat the IPA step (5–10 minutes wet contact) and let it evaporate fully.
4. Optional, for hard-water haze or odor only: a room-temperature distilled white vinegar wipe, swab or soak of 10 minutes or less, per Section 4.7. Rinse thoroughly before step 5.
5. Optional: a diluted, fully dissolved baking-soda soak for a limited time, which may help with certain chemical mixtures (see note). Never combine with vinegar.
6. Rinse with hot water, then a purified, distilled or RO water final rinse.
7. Dry flat (Section 11). If film, odor or tackiness remains on a silicone mold, proceed to the heat reset (Section 10). For TPE molds, repeat the deep clean (Section 17).
8. Record "D" in the log, including the use count since the last deep clean.

Baking soda note: dissolve baking soda completely in warm water before adding the mold so no grit remains, keep the soak time limited, then rinse thoroughly with hot water and finish with a purified-water rinse. Baking-soda paste or dry powder is abrasive and should not be used. Pharmacies are encouraged to gather their own data on this step for their specific formulations.

10. Heat Reset (Silicone Compounding Molds Only)

The heat reset drives absorbed oils back to the surface of a silicone mold so a following wash can remove them. It is mainly needed for fatty/lipid bases when film, odor or tackiness persists after deep cleaning. Do not heat reset or bake TPE molds.

Safety:

• The heat reset is not a drug deactivation or decontamination method, and heating can volatilize drug residues.
• The mold must be empty, fully cleaned (including hazardous-drug residue removal per Section 15), rinsed free of IPA and vinegar, and completely dry.
• Do not heat a mold that is wet with IPA.
• Use a dedicated, ventilated oven never used for food. Do not use a microwave or hybrid microwave/convection oven.
• Do not exceed 280°F (maximum continuous-use rating 302°F / 150°C).

Procedure:

1. Preheat the oven to 270–280°F (about 132–138°C), verified with an independent oven thermometer. Wait for the temperature to stabilize; many ovens overshoot during preheat.
2. Place the clean, dry, empty silicone mold flat, cavity side up, on a wire rack or stainless-steel grid, not touching elements or walls, with nothing on top.
3. Heat for 30 minutes. Oils may bead on the surface; this is expected.
4. Wearing heat-resistant gloves, remove the mold keeping it flat and let it cool flat on the grid. Do not quench it in cold water or wipe hot cavities.
5. Wash again with hot approved detergent, rinse with hot water, then final-rinse with purified water. An IPA wipe may follow once cool.
6. Dry flat, inspect, and record "H" in the log with oven temperature and time.

How many heat resets? There is no fixed maximum. The compounding pharmacist or head technician decides whether the mold remains suitable by inspecting it with a 3x magnifier for chips and imperfections, checking that it still flexes normally (no stiffness, brittleness or cracking at flex points), and looking for discoloration combined with other changes. If residue persists after repeated resets, retire the mold (Section 13).

11. Drying and Storage

Dry and store every mold flat. A mold held bent, folded, rolled, propped at an angle, wedged into a container or stacked under weight, especially while warm or drying, can permanently deform its cavities. That changes cavity volume, dose weight, uniformity and release. The default is horizontal and flat on a stainless-steel grid with room for air exchange.

11.1 Drying

1. Shake off excess water gently without twisting or folding.
2. Optional: the TICKERWORKS ventilated rack allows vertical drying while holding the mold straight.
3. Do not drape molds over dowels, pegs, dish-rack tines or a sink edge, or prop them at an angle.
4. Confirm the mold is completely dry, with no alcohol odor, before use or storage. Forced heat to speed drying is not recommended.
5. Molds coming out of the dishwasher or heat reset are warm and deform easily. Move them directly to a flat grid and let them cool and dry there.

11.2 Storage

• Store flat on a stainless-steel grid, horizontal, with room for air exchange. Use grids to separate molds; do not stack molds directly or place anything on them.
• A mold may be stored face down, or face up with a single loose sheet of clean parchment over the cavities to keep dust off. Parchment should be the only thing on it.
• The Pebble Beach Removal and Washer Support Rack or the TICKERWORKS ventilated rack may be used where available. Contact support@tickerworks.com for the correct rack for your molds.
• Store in a clean, dust-protected cabinet or shelf, not sealed in airtight bags or containers. Do not squeeze a mold into a drawer, bin or box that bends it.
• Keep molds away from heat sources, direct sunlight, ozone sources (motors, UV lamps), dust and strongly scented materials.
• Label with the pharmacy-assigned ID and "clean" status and date. Re-clean before use if stored more than 30 days, or sooner per the pharmacy's SOP.
• Before use, check that the mold lies flat and the cavities are true (Section 12).

12. Inspection

Inspect each mold after every cleaning and before every use, under good lighting, with a 3x magnifier on the cavities and edges. Tilt it under a light to reveal scratches, and lay it on a flat surface to check for warping. If in doubt, show it to the compounding pharmacist or team leader.

13. Retirement Criteria

Remove a mold from service, label it "Do Not Use," and record retirement on its record card if any of the following apply:

• Cavity scratches, chips or abrasion (minor scratches on the back or rim outside the cavities are acceptable; refer doubtful cases to the pharmacist or team leader).
• Physical damage: tears, splits, cuts, cracks, pinholes or torn cavity edges.
• Tackiness, film or odor that persists or returns after deep cleaning (and heat reset for silicone).
• Loss of normal flex: stiffness, brittleness, or cracking or whitening when flexed.
• Discoloration combined with other changes. Gradual, even color change alone is normal.
• Deformation: warping, curling, set-in folds, ovaled or dented cavities, or swelling that does not resolve after drying.
• Release problems: doses consistently stick or tear on removal despite proper cleaning.
• Heat or chemical exposure: above 302°F (silicone) or 250°F (TPE), any heat reset of a TPE mold, any microwave or hybrid oven exposure, or contact with a not-recommended agent.
• End of service life (13.1).

13.1 Service life

TICKERWORKS silicone and TPE molds have a service life of 3 years from the first day of use, or 4 years from the purchase date, whichever comes first. High daily volume and multiple cleanings per day may shorten service life; retire earlier if any criterion above is met.

Dispose of retired molds per the pharmacy's waste procedures, as hazardous-drug-contaminated waste where applicable.

14. Troubleshooting

15. Hazardous Drugs (USP <800>)

TICKERWORKS makes no guarantee of cleaning, deactivation or decontamination results for any hazardous drug. Each pharmacy is solely responsible for developing, validating and documenting its own HD procedures for each specific API, including third-party analytical testing (e.g., swab or wipe sampling) where required.

Some APIs compounded in troches and RDTs are hazardous drugs (HDs). The NIOSH List of Hazardous Drugs in Healthcare Settings, 2024 moved several estrogens and estrogen combinations to Table 1, and progesterone, testosterone and other hormones also appear on the list. Confirm the current NIOSH table for each API in your formulary and follow your own USP <800> Assessment of Risk.

• Dedicate molds. Use molds dedicated to HD preparations, ideally by drug class (for example, hormones), and label them. Consider the same for sensitizing APIs. Segregate the cleaning tools used for HD molds.
• Remove HD residue first. Treat residue from NIOSH-listed drugs as HD residue and remove it with the pharmacy's established USP <800> methods (deactivation, decontamination, cleaning, disinfection), with appropriate PPE, before relying on the routine steps in this guide.
• Oxidizers. Sodium hypochlorite and hydrogen peroxide, commonly used for HD deactivation, may shorten mold life or reduce performance. Use the lowest effective concentration and contact time. After hypochlorite, neutralize with sodium thiosulfate per your SOP, then rinse thoroughly, because residual hypochlorite is what degrades the material. Inspect more often (flex, surface, color) when oxidizers are used.
• No heat as deactivation. The heat reset is not a drug deactivation method and can volatilize drug residues. Do not heat a mold that has not been fully cleaned of HD residue.
• Dishwasher. Whether dishwasher cleaning is appropriate for HD-contaminated molds is determined by the pharmacy's USP <800> Assessment of Risk.
• Waste. Dispose of wipes, swabs, rinse materials and retired molds as HD-contaminated waste per the pharmacy's procedures.

16. Cleaning Verification (Recommended)

Visual inspection does not prove that drug residue has been removed. Pharmacies are encouraged to verify their adopted procedure by swab testing, especially for potent or hazardous APIs and when changing bases.

• Swab a defined area (e.g., \~100 cm²) with a lint-free swab in 70% IPA, wiping in two directions. Submit test and blank swabs to a qualified laboratory.
• Set acceptance limits on a scientific basis, for example 0.1% of the dose, consistent with the FDA Guide to Inspections: Validation of Cleaning Processes (1993). For highly potent or hazardous APIs, consider a toxicology-based limit.
• Repeat verification when the base, API, cleaning agents, mold material or procedure changes.

Earlier TICKERWORKS study (internal, limited, for reference only): in 2018, TICKERWORKS cleaned a Pebble Beach compounding mold after compounding one DHEA formulation, swabbed a defined area with 70% IPA, and sent the swab to an outside analytical laboratory. Residue was below the detection limit against a limit of 0.1% of the dose. That single study does not validate this guide, any pharmacy's procedure, or any other compound, base or condition. The method has since been updated (Appendix B).

17. TICKERWORKS TPE Compounding Molds

TICKERWORKS TPE molds (Section 2.1) are made of FDA-grade, USP Class VI thermoplastic elastomer with no surface coating. All other sections apply except as noted here.

Diclofenac: use silicone molds, not TPE molds, for diclofenac preparations (Section 4.9).

18. Documentation and Records

• Keep one Compounding Mold Record Card per mold (Appendix A): ID, material, product code and lot when present, purchase date, first-use date, service-life end, and retirement.
• Record every routine clean, dishwasher cycle, deep clean, heat reset and inspection outcome in the Compounding Mold Cleaning Log (Appendix A) or an equivalent electronic system.
• Each log entry: date, mold ID, preparation or lot compounded, base type, HD (Y/N), cleaning type, key parameters (water temperature, IPA time, oven temperature and time), inspection pass/fail, and initials of performer and verifier. Track uses since the last deep clean.
• Retain records readily retrievable for at least 3 years (USP <795>) or longer per state law.
• Document training and competency, including surface-protection and no-bending requirements.

19. References

• USP General Chapter <795> Pharmaceutical Compounding—Nonsterile Preparations (official November 1, 2023); USP <795> FAQs.
• USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings.
• NIOSH, List of Hazardous Drugs in Healthcare Settings, 2024 (DHHS (NIOSH) Publication 2025-103).
• FDA, Guide to Inspections: Validation of Cleaning Processes (July 1993).
• TICKERWORKS silicone and TPE compounding mold specification sheets; silicone SDS; TICKERWORKS care guidance (TICKERWORKS.COM).
• Silicone chemical resistance: GE Silicones Chemical Resistance Information; Bostik Fact Sheet FS011; Parker Chemical Resistance Guide for Silicone Hose; Adpol Silicone Rubber Compatibility Tables; Rogers BISCO Silicones Chemical Resistance Guide; Dow Silicone Rubber Fluid Resistance Guide; Shin-Etsu, Characteristic Properties of Silicone Rubber Compounds.
• Smooth-On, Processing Safe-for-Food-Contact Platinum Cure Silicone Rubber.
• Alconox, Inc., Liquinox and Alconox technical bulletins.
• TICKERWORKS 2018 internal cleaning validation (internal, limited, for reference only).
• Teflon is a registered trademark of The Chemours Company; it is referenced only to describe coatings found on some metal compounding molds.

20. Important Notice, Disclaimer and Limitation of Liability

20.1 Educational and informational purpose. This guide is general guidance on the care of TICKERWORKS compounding molds, provided for educational and informational purposes only. It is not a validated cleaning, deactivation or decontamination procedure for any specific compound, API, base or hazardous drug, and it is not legal, regulatory or professional advice. It does not replace the pharmacy's own SOPs or the professional judgment of licensed personnel.

20.2 Limited basis. The content is based in part on limited internal TICKERWORKS observations and a small internal study (Section 16), which are internal, limited, for reference only. They involved specific products, formulations and conditions and may not apply to others. Third-party sources are cited for general material information and do not describe or endorse TICKERWORKS products.

20.3 No guarantee or warranty of results. TICKERWORKS makes no guarantee, representation or warranty, express or implied, regarding cleaning, deactivation or decontamination results for any compound, API or hazardous drug, or that following this guidance will achieve any particular residue level, regulatory outcome or inspection result. Any warranties applicable to TICKERWORKS products are limited to those stated in the applicable TICKERWORKS product terms.

20.4 Pharmacy responsibility. Each pharmacy is solely responsible for developing, validating and documenting its own cleaning, deactivation and decontamination procedures for compounding equipment, especially for each specific hazardous-drug API, including third-party analytical testing where required by its state board of pharmacy, USP <795>, USP <800>, and other applicable laws, regulations and guidance. Each pharmacy must also follow the SDS and instructions of cleaning-agent, base and equipment manufacturers and train and assess its personnel.

20.5 Professional judgment. The pharmacist in charge (or designated person) is responsible for deciding whether, and how, to adopt any part of this guide, and for decisions on the continued use or retirement of any compounding mold.

20.6 Limitation of liability; use at own risk. Use of this information is at the user's own risk. To the fullest extent permitted by law, TICKERWORKS and its owners, officers, employees and affiliates shall not be liable for any direct, indirect, incidental, special, consequential or punitive damages, including but not limited to product loss, patient harm, regulatory action or lost profits, arising out of or related to the use of, or reliance on, this information.

20.7 Changes and current version. This information may change without notice. The most current version is published at TICKERWORKS.com/pages/troche-suppository-mold-cleaning-guide; check there before relying on a printed or downloaded copy. Questions: support@tickerworks.com.

Appendix A. Compounding Mold Record Card and Cleaning Log

Keep one Compounding Mold Record Card per mold (ID, material, purchase date, first-use date, service-life end and retirement) and record every cleaning in the Compounding Mold Cleaning Log. Both are included as printable forms in the PDF version of this guide: download the full guide (PDF).

Appendix B. Earlier TICKERWORKS Validation (2018): Steps Retained

The 2018 Pebble Beach study (internal, limited, for reference only) used hot water, swabs, a soft brush, distilled white vinegar, 70% IPA and air drying, verified by laboratory swab testing.

Appendix C. Document History