Reference 01 / Commissioning

Dairy plant equipment commissioning guide

乳品新工厂设备调试指南

A new dairy line is commissioned phase by phase, each one gated by the last. Nothing downstream is energised until the utility feeding it is proven; no product flows until the sterile boundary holds. This guide walks the standard sequence for a Tetra Pak UHT line and the qualification evidence each phase must produce.

Scope: Greenfield UHT line
Framework: FAT → SAT → IQ → OQ → PQ
Outcome: Validated, handed-over line

Qualification framework

资质验证框架

Commissioning rides on a documented qualification chain. Each stage produces signed evidence; you do not advance on the strength of "it looked fine."

Qualification stages

Stage	中文	Proves	Typical evidence
FAT	工厂验收测试	Equipment meets spec at the vendor's works	FAT protocol, punch list
SAT	现场验收测试	Equipment performs as built on site	SAT protocol, loop checks
IQ	安装确认	Installed per drawings and P&IDs	As-built check, calibration certs
OQ	运行确认	Operates across the full design range	Sequence tests, alarm tests
PQ	性能确认	Produces to spec, repeatably, over time	3 consecutive production runs

Utilities readiness

公用工程就绪

Process equipment is only as reliable as the utilities behind it. Confirm each utility to its point-of-use specification before energising any machine - clean steam pressure at the holding tube, not just at the boiler header.

Utility acceptance targets (typical)

Utility	Point-of-use spec	Check
Culinary / clean steam	≥ 3.5 bar(g), dry, 3.9.2 quality	Pressure log + non-condensable gas test
Compressed air (instrument)	6 to 8 bar(g), ISO 8573-1 Class 2.4.2	Dew point + oil content
Sterile air	0.2 µm filtered, ≥ 0.5 bar above product	Filter integrity (bubble point)
Process water / WFI-grade	Conductivity in spec, microbial limit	Conductivity + TOC + micro
Chilled water / glycol	Design ΔT at full load	Flow + supply/return temp
Electrical / UPS	Stable supply, UPS holdover verified	Phase rotation, UPS drop test

Utilities checklist公用工程检查表

Clean steam quality test passed (dryness, superheat, non-condensable gas) per HTM/EN 285 method.
Instrument air dew point and oil content within ISO 8573-1 class; air receivers drained.
Sterile air filters installed, integrity-tested, and pressure differential logged.
Process water conductivity, TOC, and microbial results signed off against spec.
Chilled water / glycol loop balanced; design ΔT achieved under simulated load.
All motor phase rotations confirmed; emergency stops and safety interlocks proven.

CIP validation - Alcip

CIP 清洗验证（Alcip）

Cleaning is validated before production, never after. The Tetra Pak Alcip station runs the standard caustic / acid / rinse program; commissioning proves every product-contact surface sees the target temperature, concentration, flow velocity, and time - the TACT parameters.

TACT cleaning parameters (typical UHT circuit)

Parameter	Target	Verified by
Temperature	Caustic 75 to 85 °C, acid 60 to 70 °C	RTD logging at return
Action (flow velocity)	≥ 1.5 m/s turbulent in all pipework	Flow meter + pipe sizing
Concentration	NaOH 1.5 to 2.0%, HNO₃ 0.5 to 1.0%	Conductivity transmitter
Time	Per recipe, return-temp gated	PLC cycle log

CIP program flow清洗流程

01
Pre-rinse预冲洗
Push product out with recovered water to drain; rinse until clear, monitored by return turbidity/conductivity.
02
Caustic wash碱洗
Recirculate NaOH at temperature; concentration held by dosing on conductivity feedback. Removes protein and fat soils.
03
Intermediate rinse中间冲洗
Flush caustic to drain or recovery until conductivity returns to water baseline.
04
Acid wash酸洗
Recirculate HNO₃ to dissolve mineral scale (milkstone). Critical after thermal duty on Tetra Therm surfaces.
05
Final rinse最终冲洗
Rinse with clean/treated water until conductivity meets the release limit. This is the release gate for the circuit.

Thermal validation - UHT / Tetra Therm

热处理验证（Tetra Therm 杀菌机）

Thermal validation proves the line delivers the required lethality without scorching product. The controlling variable is the holding tube: product must reach sterilization temperature and be held for the full residence time at the lowest expected flow, with auto-divert protecting against any excursion.

UHT thermal targets (indirect, typical)

Stage	Setpoint	Note
Pre-heat / regeneration	70 to 90 °C	Energy recovery section
Sterilization (holding)	137 to 142 °C, 4 to 6 s	Defines commercial sterility
Aseptic cooling	down to 20 to 25 °C	Before aseptic tank / filler
Sterilization water cycle	Hold ≥ 30 min at ≥ 130 °C	Pre-production sterilization of the circuit

Auto-divert valve logic自动转向阀逻辑

If holding-tube outlet temperature drops below setpoint, the divert valve must redirect product to drain and the downstream aseptic boundary must respond - product behind the fault is never allowed forward. Commissioning verifies both the trigger and the timing.

Holding tube length/diameter verified against the validated minimum residence time at maximum flow.
RTDs at holding-tube inlet and outlet calibrated against a reference; redundant sensor cross-checked.
Sterilization (pre-sterilization) water cycle holds temperature across the whole circuit for the full time.
Auto-divert trigger temperature and response time tested and recorded.
Pressure differential across regeneration confirms sterile-side pressure exceeds raw-side (no in-leakage).

Aseptic systems & tanks - Tetra Alsafe

无菌系统与缓存罐（Tetra Alsafe）

The aseptic tank decouples the steriliser from the filler so neither stops for the other. Its integrity rests on a maintained sterile air barrier and a positive overpressure that keeps the outside world out. Commissioning proves the barrier holds under every operating transition - fill, empty, and idle.

01
Pre-sterilization (SIP)在线灭菌
Steam the tank and connected valve clusters to temperature, holding all CCPs (steam barrier temperatures, condensate drainage) for the validated time.
02
Sterile air pressurization无菌空气加压
Establish sterile-filtered air overpressure once cooled; the tank must never go to atmospheric while aseptic.
03
Barrier hold test屏障保压测试
Verify the tank holds overpressure with no make-up demand beyond the expected leak rate - a pressure-decay test proves integrity.
04
Level cycling液位循环
Run fill/draw cycles; confirm vacuum-relief and overpressure controls keep headspace pressure inside band during fast level changes.

Aseptic tank control points

Control	Function	Failure response
Sterile air barrier	Positive pressure vs. ambient	Loss of sterility alarm → quarantine
Valve cluster (steam barrier)	Steam-blocked double-seat at boundaries	Barrier temp low → close to product
Pressure monitoring	Headspace within validated band	High/low alarm + control action
Vacuum relief	Prevents collapse on fast draw-down	Sterile-air make-up on demand

Aseptic filling IQ/OQ/PQ - A3 / Flex

无菌灌装确认（A3/Flex 灌装机）

The filler is where sterility meets the package. Qualification walks the IQ/OQ/PQ chain: confirm it is installed correctly, prove it operates across its range, then prove it makes good packages, run after run.

Filler qualification activities

Stage	Activity	Acceptance
IQ	Verify install vs. drawings; calibrate sensors; confirm H₂O₂ system, web path, services	Signed install check, calibration certs
OQ	Sterilization cycle, sealing parameter windows, alarm and divert tests, fill-volume accuracy	All sequences pass across range
PQ	3 consecutive production runs at rate	Sterility + seal integrity + fill weight in spec

Sealing & package integrity封口完整性

Both seals are proven: the longitudinal seal (strip-applied and welded as the web forms a tube) and the transverse seal (the jaw system closing each package). Destructive tear-down, tightness, and dye-penetration tests confirm there is no channel for recontamination.

H₂O₂ bath concentration, temperature, and contact verified; residual peroxide in package within limit.
Aseptic chamber overpressure maintained throughout production; loss-of-overpressure forces controlled stop.
Longitudinal and transverse seal parameters within validated window; tear-down inspection passes.
Fill volume accuracy and repeatability inside tolerance across the speed range (OQ).
Three consecutive PQ runs meet sterility, seal integrity, and fill-weight criteria.
All filler alarms route to PlantMaster with correct severity and operator guidance.