Standard SOP Compilation Outline for Operation, Inspection and Maintenance of Plaub Hom Kev Tiv Thaiv -Corrosion Heating Tubes hauv Fermentation Rhiav

# Standard SOP Compilation Outline for Operation, Inspection, and Maintenance of Four Types of Anti-Corrosion Heating Tubes in Fermentation Workshops ## General Part: Universal SOP General Provisions Valid for All Four Heating Tube Types ### 1 Purpose and Scope 1.1 Standardise the whole-process operation, patrol inspection, periodic maintenance, fault disposal, idle storage, and scrapping management of heating tubes; eliminate human-induced equipment damage and fermentation batch quality risks. 1.2 This section pertains to four categories: 316L stainless steel heating tubes, pure titanium heating tubes, quartz heating tubes, and PFA coated heaters. It is pertinent to biopharmaceutical sterile fermentation, food fermentation, chemical intermediate production, and laboratory test tank posts. 1.3 Adhere to the factory's GMP quality system requirements; all operation records are capable of supporting a comprehensive traceability audit. ### 2 Post Responsibility Division 2.1 Production operators: Daily startup/shutdown operation, routine patrol inspection, real-time parameter recording, basic pipeline cleaning, abnormal alarm first report. 2.2.2 Equipment maintenance technicians: Periodic disassembly inspection, calibration of sensors and interlock systems, accessory replacement, fault troubleshooting, offline protective treatment, annual overhaul. 2.3 Quality QA personnel: Conducting routine spot checks to ensure the integrity of the equipment archive, verifying the status of medium contaminant sampling, and confirming the operation status of heating equipment in accordance with GMP regulations. 2.4 Equipment management engineer: optimisation of material selection, full-lifecycle performance evaluation, supplier technical docking, preventive maintenance plan scheduling, and SOP version updating. ### 3 Universal Safety Operation Rules 3.1 Prior to any disassembly or maintenance, disconnect the heating power, close the inlet and outlet valves, empty the medium and residual cleaning liquid, and implement the locking tag-out (LOTO) procedure. 3.2 It is prohibited to alter the threshold parameters of PLC interlocks without the written consent of equipment engineers. 3.3 Maintenance must be conducted using specialised tools that are matched to the equipment. Metal hard tools are not permitted for titanium, quartz, and PFA equipment. 3.4 A full-load demonstration run of at least one batch is required following all maintenance operations, and records can only be signed off if no abnormalities are present. 3.5 Standardised forms must be used to document all inspection, maintenance, and defect disposal activities, including the date, operator signature, and accompanying test photos. ## Chapter 1 SOP for 316L Stainless Steel Heating Tube ### Section 1 Standard Operation Steps for Startup, Operation, and Shutdown 1. Pre-start inspection: Verify the smoothness of the exhaust valve, the normal indication of the alkali temperature interlock, the absence of any visible rust on the tube surface, and the presence of an intact PTFE isolation layer between the tube bundle and carbon steel support. 2. Gradual temperature rise operation: The heating rate is managed at a rate of no more than 0.8℃/min to prevent a rapid temperature rise that could result in a weld thermal stress crack. 3. The following parameters are monitored in real time: medium chloride concentration, alkali cleansing peak temperature, heating power fluctuation, and exhaust pressure. 4. Standard shutdown procedure: halt heating, complete CIP cleaning, dry air blow-dry pipeline interior, and close blind plates for long-term idle standby. ### Section 2 Daily Routine Patrol Inspection Items (Recorded per Shift) 1. Examine the outer wall of the tube bundle for rust spots, local discolouration, and scale accumulation. 2. Verify that the alkali interlock sensor display is functioning properly and that the alarm function is not being manually shielded. 3. Listen to the exhaust pipeline for any anomalous air blockage noise; if the exhaust is unsmooth, remove the sediment. 4. Evaluate the trend of scaling growth by recording real-time heating power. ### Section 3 Periodic Maintenance SOP (Standard Cycle Execution) 1. Monthly: Online CIP acid descaling, exhaust valve disassembly cleansing, and statistical analysis of chloride data. 2. Bi-monthly: Supplementary local passivation for corroded areas, weld visual inspection, and full ultrasonic wall thickness scanning. 3. Quarterly: Replacement of the support isolation strip, calibration of the interlock sensor, and full tube bundle light pickling passivation. 4. Semi-annual: Internal cleansing, partial disassembly, and magnified inspection of weld microcracks. 5. Annual: Evaluation of residual service life, replacement of all ageing PTFE gaskets, and full hydraulic pressure tightness test. ### SOP for Common Fault Disposal in Section 4 1. weld rust pitting: Isolate tube bundle → wall thickness test → mild corrosion: local passivation → severe penetration: apply for replacement. 2. Automatic acid circulation descaling is initiated by a continuous power increase caused by scaling. If the effect is inadequate, the process is repeated twice, and the device is then disassembled for offline cleaning. 3. Alkali over-temperature alarm: Immediately interrupt thermal power, extend the duration of clear water flushing, and calibrate the interlock sensor. ### Section 5 Long-Term Idle Storage Protection SOP 1. Post-shutdown treatment: Comprehensive acid-base cleaning, dry air thorough blow-dry, and supplementary weld passivation. 2. Blind plate seal all ports, wrap waterproof film with desiccant, and position on a plastic support frame for sealed storage. 3. Re-passivation and re-sealing are required every six months for dormant equipment that has been inactive for more than six months. Additionally, regular inspections are conducted every two months. ## Chapter 2 SOP for Pure Titanium Heating Tube ### Section 1 Standard Operation Steps for Startup, Operation, and Shutdown 1. Fluoride detector zero calibration, aeration equipment standby prepared, all titanium-carbon steel contact positions protected by intact PTFE isolation sleeves, and no scratches on the tube surface. Pre-start inspection. 2. Startup sequence: Initialise the aeration system, then commence feeding once the dissolved oxygen level reaches 8 mg/L. Subsequently, segmented heating is implemented. 3. The aeration device must be operational during the entire cleaning cycle to ensure the circulation of oxygen-rich water, which is a mandatory requirement for CIP cleaning. 4. Shutdown protection: Prior to emptying the conduit for standby, conduct a 30-minute circulation of oxygen-rich water. ### Section 2 Daily Routine Patrol Inspection Items (Recorded per Shift) 1. Fluoride online detector with real-time readings and an alarm for no trace fluoride. 2. Tube surface examination for translucent white matte etching traces and large-area scratches. 3. Check the tank bottom outlet for any rust sediment that has fallen from the isolation sleeves. 4. Document the range of surface electrochemical potential fluctuations. ### Section 3 Periodic Maintenance SOP (Standard Cycle Execution) 1. Fluoride detector data archiving, exhaust sensor cleaning, and aeration equipment maintenance are performed on a monthly basis. 2. Quarterly: Fluoride pipeline interlock simulation test, full surface potential scanning, and inspection and replacement of all isolation sleeve ageing. 3. Semi-annual: A thorough flushing of pipeline rust sediment and a 30-minute full-bundle oxygen-rich water circulation passivation. 4. Annual: Renewal of full isolation accessories, hydraulic tightness test, and offline enhanced passivation for low-potential tube bundles. ### SOP for Common Fault Disposal in Section 4 1. Fluoride etching in a milky white colour: Check the fluorine content of the medium and disconnect the fluoride source. Mild etching necessitates the repair of oxygen-rich water circulation. Severe uniform wall thinning necessitates the replacement of the tube bundle. 2. Rust sediment pollution: Discontinue operations, flush the tank and pipeline completely, and replace all PTFE isolation sleeves that have been damaged. 3. Continuously low potential value: Conduct an offline enhanced passivation treatment and inspect the aeration system for any malfunctions. ### Section 5 Long-Term Idle Storage Protection SOP 1. Pre-storage cleaning: A complete cleansing with oxygen-rich purified water, followed by a thorough blow-dry to prevent the formation of residual water film. 2. Storage zoning: Nylon support placement, soft plastic scratch-proof packaging, and independent fluorine-free warehouse. 3. Visual inspection on a bi-monthly basis; equipment that has been inert for three months necessitates oxygen-rich water recirculation re-protection prior to re-sealing. ## SOP for Quartz Anti-Corrosion Heating Tube in Chapter 3 ### Standard Operation Steps in Section 1: 1. Pre-start inspection: The heating rate limiter parameter is normal, the alkali pipeline mechanical interlock is in a locked state, and all rubber shock absorption pads have been fastened. 2. Startup control: The heating rate is strictly restricted to a maximum of 0.4℃/min, and a rapid temperature increase is prohibited to prevent thermal shock. 3. Flow control: The frequency of the circulating pump is altered to maintain a flow velocity of <=0.6m/s and to mitigate the vibration caused by liquid impact. 4. CIP restriction: The interlock for the alkali liquid supply valve has been forced closed, allowing only neutral disinfectant and dilute acid to circulate. 5. Shutdown: Prior to emptying the pipeline medium, cease heating and allow the medium to cool naturally to room temperature in order to prevent an abrupt cold shock. ### Section 2 Daily Routine Patrol Inspection Items (Recorded per Shift) 1. A rapid examination of the surface for surface frosting and minute cracks is possible through light transmission. 2. Check the vibration of the support bracket to ensure that the tube bundle is not loosely swaying. 3. Record of the monthly mandatory alkali interlock forced shutoff simulation test. 4. Real-time recording of the heating rate and pump flow velocity parameters. ### Section 3 Periodic Maintenance SOP (Standard Cycle Execution) 1. Shock pad fastening inspection and full light gearbox fracture scanning inspection are conducted biweekly. 2. Monthly: Soft sponge surface cleaning, pump flow frequency adjustment, and calibration of the heating rate controller. 3. Quarterly: Low-pressure water tightness test, replacement of all ageing damping rubber. 4. Semi-annual: Complete overhaul of the alkali interlock valve, as well as the unified sorting and scrapping of frosted and fractured quartz tubes. 5. Annual: Re-inspect all plastic thread protective covers and foam buffers, and complete the disassembly of the light transmission. ### SOP for Common Fault Disposal in Section 4 1. Tube rupture: Immediately disconnect power and valves, drain and discard the contaminated medium, and replace the entire shock absorption assembly with a new quartz tube. 2. Circulate dilute acid neutralisation to achieve surface permanent frosting. If frosting coverage exceeds 30%, discard the tube bundle. 3. Abnormal vibration: Replace ageing shock pads, secure supports, and decrease the flow velocity of the pump. ### Section 5 Long-Term Idle Storage Protection SOP 1. Pre-storage cleaning: Wipe the shock pads with a soft sponge, drain the liquid completely, and remove the pads that are ageing. 2. Single tube is wrapped in thick bubble wrap, placed in a foam-lined wooden box, and stacked in a low-vibration, constant-temperature warehouse in limited layers. This packaging is shockproof. 3. Before being repurposed, idle equipment must undergo a full light gearbox re-inspection, while monthly packaging deformation and scratch inspections are required. ### Chapter 4 Standard Operating Procedures for PFA Coated Heaters ### Section 1 Standard Operation Steps 1. Pre-start inspection: The temperature interlock sensor shows a normal reading, the pipeline front solid particle filter is intact, and the coating surface is free of any visible blistering or flaking. 2. Operation temperature limit: Maintain a continuous medium temperature below 90℃ for an extended period of time, and refrain from operating in close proximity to the 95℃ interlock threshold. 3. Post-CIP mandatory program: The system must autonomously conduct a 40-minute slow cooling process following high-temperature cleaning; manual skipping is not permitted. 4. Disinfection control: The concentration of hydrogen peroxide was diminished by 50% to mitigate the oxidative ageing of the coating. ### Section 2 Daily Routine Patrol Inspection Items (Recorded per Shift) 1. Visually inspect the coating surface for blisters, yellowing, and shallow scratches. 2. No long-term over-temperature alarm; medium continuous operating temperature curve recording. 3. Check for filter cartridge blockages and promptly replace them if the flow resistance increases abnormally. 4. I confirm that the delayed cooling program is executed automatically following each CIP cycle. ### Section 3 Periodic Maintenance SOP (Standard Cycle Execution) 1. Monthly: Statistical analysis of temperature data, filter cartridge replacement, and a comprehensive visual scan of the coating surface. 2. Temperature interlock sensor calibration and self-cleaning filter function testing are conducted bimonthly. 3. Quarterly: The sharp metal support liner is replaced with flexible plastic pads, and the thickness of the multi-point coating is measured. 4. Semi-annual: Conduct a coating adhesion sampling test, count the area of blister damage, and arrange for an overall replacement if the damage ratio exceeds 5%. 5. Hydraulic tightness testing, parameter optimisation, over-temperature fault data sorting, and the renewal of all soft plastic sealing plugs are conducted annually. ### SOP for Common Fault Disposal in Section 4 1. Coating blistering and yellow ageing: Calibrate the temperature interlock and implement a gradual cooling program. Directly replace the heater with large-area peeling. 2. Scratches that penetrate the substrate necessitate the activation of the filter's self-cleaning feature and the replacement of the filter element. Additionally, the entire heater must be replaced to prevent the discharge of rust. 3. Continuously excessive power consumption: If the area of the coating blister coverage exceeds 5%, arrange for a planned replacement. ### Section 5 Long-Term Idle Storage Protection SOP 1. Pre-storage treatment: Abrasive particles are flushed with low-flow soft water, and the item is then dried using normal temperature dry air with a blow-dryer. Hot air drying is prohibited. 2. Anti-scratch storage: Horizontally placed on plastic buffer padding, wrapped with soft non-woven fabric, sealed with plastic soft plugs, and kept away from high-temperature heat sources and strong oxidants. 3. Bi-monthly coating inspections are conducted, and inactive equipment that has been idle for four months requires re-flushing and re-sealing prior to its re-use. ## Chapter 5 Supporting Auxiliary SOP Attachments (Unified for Four Heating Tube Types) ### Attachment 1 Equipment Fault Emergency Disposal SOP Standardised process of alarm discovery → power-off isolation → sampling retention → fault positioning → disposal implementation → post-disposal trial run → fault record filing, including emergency material list for each heating tube type. #### Attachment 2 Annual Preventive Maintenance Execution SOP: Maintenance record form template, maintenance after-trial run confirmation sheet, residual service life evaluation table, and monthly/quarterly/semi-annual/annual maintenance task checklist. ### Attachment 3 Equipment Long-Term Idle Storage and Reactivation SOP Unified cleansing, drying, sealing, periodic inspection, and pre-production re-inspection operation steps for all heating tube materials. ### Attachment 4 Equipment Scrapping Disposal SOP Judgement criteria for scrapping, scrapping application approval process, classified disposal requirements for stainless steel scrap, titanium fluorine-containing waste, quartz solid waste, and PFA fluorine hazardous waste, and waste transfer record filing rules. ### Attachment 5 GMP Record Archiving Management SOP Standard requirements for all patrol, maintenance, test, and fault records, dual storage of electronic and paper documents, archive retention period regulation, and audit and fast retrieval catalogue preparation requirements. ## Chapter 6 SOP Version Management and Training Requirements 1. Trigger conditions for version upgrades include the following: Working condition transformation, equipment material replacement, significant fault recurrence, and an update to the GMP supervision standard. The version number is revised and distributed uniformly by the equipment department. 2. Training implementation: Prior to independent post operation, all operators and maintenance technicians must successfully complete a written and practical assessment. Training records are then archived in personal post files. 3. Regular SOP retraining: Conduct a full staff retraining every six months, with a particular emphasis on the differentiated forbidden operation items of four heating tube materials in order to mitigate human-induced equipment failure. ## Summary This SOP compilation outline differentiates the operation, inspection, and maintenance specifications for four heating tubes based on their distinct corrosion failure, structural damage, and ageing mechanisms. Each set of independent SOPs delineates the post-operation steps, patrol focus, periodic maintenance cycle, defect disposal logic, and idle protection standards. These procedures are complemented by auxiliary procedures for emergency, maintenance, storage, scrapping, and archive management. The comprehensive implementation of standardised classified SOPs can effectively standardise the operation behaviours of frontline staff, reduce accidental equipment damage caused by non-standard operation, stabilise the long-term safe and low-loss operation of fermentation heating systems, and ensure that all operation and maintenance records complies with GMP audit traceability requirements.