In this guide 6 sections
Paper travellers suit one moulding line making one product under a steady supervisor. Electronic batch records win once several lines, outside sterilisation loads and many rejection reasons meet. Judge both by one test: how quickly can you answer a question about a single lot, with proof?
Where a paper traveller still works
A traveller is a printed sheet that rides with the lot, carrying the resin lot, the mould number, the operator’s initials and the count at each stage. For a single line making one syringe barrel, that is often enough.
Paper is cheap to start and needs no training. It also fails quietly. A coffee ring hides a figure, and a page goes missing between packing and sterilisation dispatch, so the gap stays hidden until a buyer asks for the record.
Paper holds up best when you run few products, few shifts and one supervisor who reads every sheet before it leaves the floor.
- One product family and one moulding line
- A single shift with one reviewer
- Sterilisation done inside the plant
- Few customer audits in a year
Lot yield is where the two split first
Yield on paper is a sum done at the end of the lot by someone with a calculator. Input shots, good parts, flash, short shots and sink marks all land in different boxes, so errors survive for months.
Electronic records take the count at the station. The moulding cell reports shots, the inspection bench reports rejects, and the lot yield appears without anyone adding it up by hand. A drop on mould four shows the same day, not at month-end review.
The trade-off is entry discipline. A tablet at the bench needs a rule for who types and who checks.
Linking a sterilisation load to the lots inside it
This is the hardest link in a disposables plant. Lots are packed into shipper cartons, cartons go onto pallets, and pallets go into an ethylene oxide chamber or out to a contract steriliser. One load carries many lots, and one lot can split across two loads.
On paper you tie them together with a load sheet and a pen. When a biological indicator fails, someone must find every lot on that load by hand, and hours pass while shipped quantities stay unknown.
A system holds the many-to-many link. Scan the carton, scan the pallet, scan the load. A failed indicator then returns a list of lots, customers and shipped quantities in seconds.
- Load number, chamber and cycle record
- Cartons and pallets per load
- Indicator result and release date
- Lots split across more than one load
Rejections and rework need a reason code
Operators on paper write “bad” or “flash” in a margin, and nobody can total those notes across a quarter. The pattern behind a recurring black speck stays invisible because every sheet describes it differently.
A short list of reject codes on a screen fixes this. Short shot, contamination, wrong weld, torn pouch, label error. Each code is tied to a mould, a machine and a shift, and rework gets its own count so it never inflates the good-part tally.
Keep the code list short. Fifteen codes get used. Sixty get ignored.
- Reason code, mould and machine
- Rework count kept apart from good parts
- Scrap weight against resin issued
- Who approved a concession
Choose with a retrieval test
Pick a shipped lot from six months back. Ask your team to produce the resin certificate, the moulding record, the inspection results, the sterilisation load and the customer shipment. Time it with a stopwatch.
If it takes under ten minutes on paper, stay on paper and tighten the sheets. If it takes half a day, or two people disagree about the answer, you have your case for software. Start with the sterilisation link and the reject codes, then widen to the rest of the floor.
Paper or electronic scoring sheet
One sheet carries two columns headed paper and electronic, plus six rows. The rows are lot yield, sterilisation load link, reject logging, shift handover, audit retrieval time and the cost of a lost sheet. Each row has a field for your measured retrieval time and a tick box for the owner of the entry.
Open a blank worksheet to printQuestions owners ask
Can we run paper and electronic records side by side?
Yes, for a pilot. Run one line electronically while the rest keep travellers. Compare lot retrieval times after a month before deciding on the other lines.
Does a contract steriliser change the answer?
It raises the value of electronic links. The load number arrives on their report, and you need to match it to your lots without retyping it from a faxed or scanned page.
Who signs an electronic batch record?
The same roles that sign paper: operator, line inspector and a release reviewer. The system also records who changed what and when, which a pen on a sheet cannot show.
What should we digitise first?
Start where paper hurts most. For most disposables plants that is the sterilisation load link, followed by reject codes at the inspection bench.