Aseptic drug conveying line design points from cleaning to sorting full analysis

Did you know. Every year, 37% of pharmaceutical contamination occurs in the conveyor chain - just because one less sterilisation process is done on the conveyor belt. Imagine a patient getting an infection from a supposedly life-saving injection that was contaminated by dust on the conveyor line...it's not scary. Today, we're going to break it down and talk about how a novice can learn the ropes of a sterile drug conveyor line from scratch, especially those deadly details hidden in the cleaning, sterilisation and sorting.

First, why is the aseptic conveying line the "lifeline" of the pharmaceutical plant?

Simply put, ordinary conveyor lines make pills fall to the ground and pick them up and blow on the dust and they're still edible (don't take it seriously), but a single speck of dust on sterile medicines (like injections and biologics) can kill a person.GMP standardDirect regulation: aseptic production lines must meetClass A cleanliness--More than three particles of 0.5 microns per cubic metre of air are considered substandard. How strict is this standard? It's 100 times cleaner than an operating theatre!

Second, the conveyor way to choose the wrong all lost

Four common ways to compare:

To cite a negative example: a pharmaceutical company used an ordinary roller line to transport bottles of injection solution, resulting inWelded seams on conical drumsNo polishing in place, bottle scratches and leaks, and the whole batch is scrapped. So remember.Parts in direct contact with pharmaceuticals must be 316L stainless steelThe surface should be ground like a mirror (roughness Ra ≤ 0.8 μm).

Third, clean design is a life preserver, not a decoration.

There are three potholes that newbies are most likely to fall into:

• ​Cleaning In Place (CIP): Pipes must be smooth on the inside like a straw and have a slope of ≥3° (think of it as a slide angle), otherwise the water will pool and grow bacteria
• ​Sterilisation Blind ZoneThe bottom of the conveyor belt, the motor gap, you've got to use theVHP Vaporised Hydrogen PeroxideFumigation - ordinary ultraviolet light can only reach one side of the medicine, the back side will still have bacteria.
• ​Dynamic pollution control: rubber-coated rollers release toxic dust at high temperatures, and have to be replaced withHard chrome plated stainless steel + food grade lubricant​

Like that patent case is smart: add in the middle of the conveyor lineFlip arm, so that both sides of the pill are illuminated by UV light. It's like frying a steak by turning it over to cook it!

Four, sorting link anti-pollution trick

Sorting carton friction, bar code wear is not trivial. An enterprise has been due to the failure of code scanning the whole batch of drugs stranded in the warehouse expired. The solution has three axes:

1. ​Polyurethane seamless beltsSoft than rubber belts, tensile strength ≥ 15MPa also do not fall off the chip
2. ​Laser Scanner Protective Cabin: a "dark room" to keep out the light (think sunglasses for the scanner).
3. ​Negative Pressure Dust Cover: Dust raised during sorting is sucked away instantly to avoid mixing with the next batch of drugs.

Special note: Sorting areas are the easiest to ignoreAirflow at conveyor belt interface. Open isolators must doAirflow pattern verification, otherwise dirty outside air backs up - it's like having sterile surgery with the windows open!

Fifth, the newbie must step on the pit and fill in the pit guide

Recently to help the pharmaceutical company acceptance found a true story: equipment vendors boast "fully automatic sterile line", the results of the investigationMaterial ReportI found out that the lubricant didn't have NSF H1 certification (not even food grade) and returned it on the spot. So dock the supplier dead on three documents:

1. GMP/FDA material testing report (especially for 316L stainless steel)Molybdenum content)
2. Surface microbiological residue data (≤5 CFU/100cm² to be considered compliant)
3. Wear curves of key components with warranty ≥ 5 years (fatigue life of chain, roller)

There are more hidden: many people think that the clean area installed a high-efficiency filter on the end, in fact, theSelf-cleaning function of the transfer windowMust be verified - we have measured a factory transfer window, open the door 5 seconds after the cleanliness plummeted from class A to class D...

When I was involved in the commissioning of the first aseptic line ten years ago, because I didn't find theDrum dynamic balance deviation 0.1g-mm(The standard is ≤ 0.05g-mm), resulting in filling machine vibration leakage. Now see the new people make the same mistake, really want to yell: don't believe in manufacturers blowing "micron-level accuracy", take the laser vibration meter to check for themselves!