Sealant liquid (jelly-like gel) replacement cycle standard
It is divided into two parts: fixed cycle and immediate replacement judgment conditions, which are suitable for different working conditions in pharmaceutical GMP and electronic dust-free workshops:
1. Regular complete replacement cycle (empty the entire tank and replace with new gel)
Frequent VHP hydrogen peroxide fumigation of A/B grade sterile areas, operating rooms, P2/P3 laboratories
Replace once every 6 months
The fumigation of oxidants will accelerate the aging, stratification, and blackening and precipitation of the gel, easily causing leakage of the seal. GMP verification pays special attention to this.
General pharmaceutical clean areas, thousand-level/electronic clean workshops, and less fumigation environments
Replace the entire tank once every 12 months (1 year)
Cleanrooms with low dust, stable temperature, and almost no space sterilization
The highest quality silicone-based sealant can be extended to once every 2 years for replacement, but it is not recommended to exceed 2 years
Note: Only replenish and do not add (no replacement)
Monthly inspection only replenishes the liquid: when the liquid level is below the standard scale, there is a small amount of evaporation loss, directly add the same type of new gel;
Do not mix large amounts of new and old gels for long-term use, and if the bottom of the tank accumulates dust and deteriorates, the entire tank must be cleaned and replaced.
2. If any of the following occurs, immediately replace the entire tank, without waiting for the cycle
The gel becomes black, turbid, stratified, or there is a large amount of dust or drug residue on the bottom of the tank;
The gel becomes hard, shrinks, has bubbles, or loses the jelly-like elasticity;
During PAO/DOP leak detection, the sealing edge of the liquid tank on the filter continuously leaks particles (excluding filter membrane damage);
Each time the high-efficiency filter is replaced, if the appearance of the gel is dirty, clean the tank and replace the gel simultaneously;
When condensate water and disinfectant splash into the liquid tank in large quantities, the gel is diluted and damaged;
Mixing different brands of sealants will cause incompatibility and stratification.
3. Key operation reminders
Replacement operation: Must scrape off all the old gel, wipe the tank wall with isopropyl alcohol, and completely dry it before refilling with new gel. Do not directly overlay the old gel;
Different brands of sealants are not allowed to be mixed, as they will undergo chemical reactions and lose effectiveness;
After the replacement is completed and solidified, a PAO scan leak detection must be performed and records must be retained to meet GMP traceability requirements.
4. Simple cycle quick reference table