When sourcing customized beverages, whether a private label kombucha, contract brewed lager, canned cold brew or sparkling water flavored with someone else’s name ultimately your challenge will be the same. Your challenge is not with the recipe for your product. Your challenge will be to prove to the various people involved that your production line and packaging material are clean and fit for consumption. A unique factor of custom drink manufacturing, compared to manufacturing common beverages, is that many times during the same day the production line will produce very different types of beverage products. One time it may produce a citrus beverage; the next time it may produce an oat beverage. Your cleaning validation must account for both beverages and any other potential beverage being produced on that line. Your cleaning validation must also allow for the different temperatures and chemistries that may be produced during the package manufacturing. Therefore, the challenge of custom drink manufacturing is not a simple task of manufacturing the same item for an indefinite period of time.
This article presents two aspects of the same challenge, how to produce clean packaging for a beverage and how to produce a sanitary production facility. The second aspect relates to the physical equipment used in the production facility (sanitary fittings, sanitary pipes, sanitary valves, sanitary spray devices, etc.) and is the component of the facility that establishes whether or not the first aspect is possible.
The Package sanitation system is concerned with the packaging material’s cleanliness through the rinsing and pre-cleaning of these items as well as ensuring that they meet the FDA 21CFR177 and EU 1935\2004 compliance requirement for food contact material and any applicable PFAS/Fluorine testing for the paper and moulded fibre used to make the packaging. The Packaging sanitation system is also responsible for all pre-fill processes such as CIP cleaning of the production process and equipment (i.e.: Tanks and Vessels) prior to being connected to the fill positions. The Package Sanitation system is concerned with ensuring that all potential growth bioburdens are eliminated prior to being placed in the container using the Alkaline Wash, Acid Wash and Final Sanitization processes. In conclusion, if any part of the beverage sanitation system is not sanitised, then the microbiological testing of the finished product will fail.
Table of Contents
- What "TOF" Means in a Beverage Context
- Packaging Sanitation: Container, Closure and Fill Zone
- Where Beverage Packaging Actually Fails
- Production Sanitation: CIP, SIP and the Wet Side
- Tanks, Vessels and Spray Balls
- The Hygienic Parts That Decide Whether CIP Works
- The Standards You'll Be Audited Against
- Don't Overlook the Dispense Side
- A Practical Sanitation Checklist
- Frequently Asked Questions
- References
- Conclusion
What "TOF" Means in a Beverage Context
To start, we need to clarify what "TOF" means, as it has three different meanings in the beverage industry, and confusing them really complicates things.
The first meaning is the brand name of the equipment. TOF is an Italian company founded in the 1940s close to Lake Orta in the region called Cusio, which is positioned between Piedmont and Lombardy. The plant produces items for beverage distribution, including couplings for S, D, A, M, G systems, taps, columns, pressure regulators, etc., and it also manufactures specialized cleaning adapters, which help to conduct cleaning solutions through the distributing pipe. The head office is in Brooklyn, and the distribution center in Dayton. The most important thing to mention in this article is that the product line includes items designed for sanitary procedures — they use only food-safe materials, and some items go as far as products made from stainless steel.
The second meaning refers to a test for compliance with packaging standards. In this case, TOF means total organic fluorine, a method for testing food-contact packaging for PFASs. Total fluorine measures the total number of fluorine atoms which is why it gives an overestimated amount. TOF, on the other hand, investigates synthetic organofluorine compounds by means of combustion ion chromatography. Several regions and retailers today established a threshold of 100 ppm and start demanding reports that include TOF instead of claims like "fluorine-free".
Third, in terms of content marketing, TOF refers to top of funnel in SEO terminology — at the research stage when the customer has not identified specific suppliers.
Each of these definitions speaks about the same issue — who is responsible for proving the cleanliness of beverage equipment? We will consider this topic further in the article.
Packaging Sanitation: Container, Closure and Fill Zone
The process of ensuring that the packing container and its closure are safe from microbial contamination while filling, as well as maintaining that state until the moment the consumer opens the package, is called packing sanitation.
Packaging sanitation can be divided into four zones that need to be addressed within the custom beverage program.
The container. PET preforms are shipped from the molding supplier nested in a liner bag and should not come into contact with the air in the manufacturing plant before blowing. Glass containers are inverted and washed with filtered or otherwise purified water, because if the product is going to be sitting on the shelf for months the quality of rinsing water is as important as the quality of the container. Cans go through the use of air knife, and in case of aseptic lines are rinsed before filling with a special fluid. Cans are a commonly known format, as they are manufactured and filled in a single process, but still the cap and seamer pose a contamination risk.
The closure. Caps, crown corks and lids are exposed to the mold-release agents and dust during manufacturing and transportation. Therefore, the sterilization of caps using dry or wet sterilization (peracetic acid or hydrogen peroxide) is conducted before the sealing takes place, even in case of hot-fill or cold-fill lines.
The filling environment. This zone makes custom beverage filling difficult. Each of the production lines that processes several products has its temperature range varying from 25˚C to 92˚C, so the infection risk varies after line changeover. The solution is to find a filling machine that has a defined cleaning program and has the option of being fogged or UV treated after every run.
Compliance of food-contact materials. Each surface of the product that touches the drink (bottle, cap, gasket, filling nozzle, transfer hose) must be compliant. In the USA it is the FDA packaging regulation and in the EU Packaging Regulation 1935/2004/The general principle is straightforward — a food-grade material has to be documented, inert, non-absorbent and stable at the temperatures it will actually see, not just at the temperature it was tested at.
It’s important to point out that packaging sanitation is not a chemical problem it is a sequence problem. To begin with, rinse before filling, sterilize before sealing, and finally, verify before release. Each type of packaging failure discussed below is an interruption in the above sequence.
Where Beverage Packaging Actually Fails
The causes of recalls and stoppages in beverage plants are all quite simple. You can put them in this order according to frequency.
| Failure point | What goes wrong | Typical root cause |
|---|---|---|
| Cap / closure | Mould or yeast recovered from the closure after fill | Sterilisation step bypassed on a short run; chemical dose drifted and nobody re-titrated |
| Filler valves | Biofilm in the valve body, intermittent micro positives | Cleaning cycle doesn't reach the valve internals; disassembly frequency too low |
| Filler bowl / bowl seals | Product residue accumulates at the seal | Worn gaskets, crevice at the seal seat, no inspection window |
| Transfer hose and fittings | Residue at a clamp joint or a hose barb | Mismatched gasket material, over-compressed clamp, rough internal weld |
| Dead legs | Product or cleaning solution pools and doesn't move | Legacy pipework added for a second product; branch longer than 2–3 pipe diameters |
| Rinse water | Container contamination before fill | Filter change overdue; rinse water not monitored for conductivity or micro |
| Changeover between products | Allergen carryover or off-flavour | Cleaning procedure written for one product, applied to a different matrix |
So far, it can be seen that the majority of problems are not related to the effectiveness of the sanitizing equipment. Rather, the main problem lies in the inability of the disinfectant to come into contact with the surface that requires disinfection.
Production Sanitation: CIP, SIP and the Wet Side
Clean-in-place, abbreviated as CIP, is a closed-loop procedure that eliminates impurities inside tanks, pipelines, and equipment without the need to disassemble them. A validated CIP process is usually not regarded as a washing method but consists of a series of steps with each stage having its unique temperature, concentration, flow velocity, and contact time.
The standard CIP process in beverage production involves these steps:
- Pre-rinse. Recover and wash the loosened product with water. This step reduces the organic burden on the subsequent cleaning agent.
- Alkali wash. A cleaning agent in the form of sodium hydroxide (usually with a concentration of around 1-2 percent) at a higher temperature is applied in order to saponify fats and hydrolyze proteins.
- Intermediate rinsing. Eliminate the alkali before it neutralizes the acid.
- Acid wash. Apply nitric, phosphoric, or other acids in order to remove mineral deposits.
- Final rinse and disinfection. Use a chemical disinfectant (peracetic acid is the best selection) or hot water (and then apply a rinse-free process) for final cleaning.
The engineering restrictions that provide the success of the whole process are the velocity of the flow. The CIP system depends on the flow in the turbulent mode to create the shear stress that is the force that lifts the contaminations from the surface. In practice, it is necessary to ensure 1.5-2.0 m/s in the cleaning area. When the flow is more than 1.5 m/s, the process is based on chemistry alone.If you want the operational detail on cycle design, chemical titration and validation records, the fundamentals are covered in this walkthrough of CIP practice for manufacturers, and it's worth reading before you write your own SOP.
Sterilisation-in-place (SIP) is a process similar to CIP to some extent. While CIP is responsible for cleaning, SIP disinfects a surface, usually through saturated steam at 121 degrees Celsius or higher for some time or using an approved chemical. SIP is especially important for aseptic lines or products that do not receive any terminal disinfection. The reason both CIP and SIP are mentioned together is that they put the same requirements on design and equipment: no cracks, no troublesome high places that cannot be vented, no places that cannot be cleaned, and no ‘dead ends’.
This last point creates many debates. Traditionally, the rule says that the branches should not exceed three pipe diameter long. Some guidelines of EHEDG and the modern practices of dairy or beverage industries recommend two pipe diameter length or even one as a maximum. Each high-care facility provides its own recommendations, sometimes requiring the use of no-dead-leg clusters. There is no universal maximum dimension, as the right value depends on cleaning validation.
Tanks, Vessels and Spray Balls
Tank cleaning is completely different from line cleaning, and this is where most people trip up. It is impossible to achieve 1.5m/s in turbulent flow within a 20,000-litre tank because there is no pipe to cause turbulence. Rather, tank cleaning is achieved via impingement, where the cleaning solution is sprayed onto the tank walls with so much force that the impact does the rest.
The cleaning devices that are used for tank cleaning can be broken down into three categories. The static spray ball is a hollow sphere that sprays the cleaning solution in a set manner — it is effective, low-cost, low-flow and relies on chemistry rather than impact, making it excellent for tanks that need light cleaning but not as effective for tough residue removal. The rotary spray ball and rotary jet head operate using the thrust of the jet itself to spin — therefore, they create a much higher concentration of cleaning pattern than static spray balls. Finally, spray nozzles and tank cleaning devices are used to clean narrow pipes, crevices and other difficult-to-reach geometry.
The decision-making process of choosing among cleaning devices revolves around the types of contaminations encountered and tank geometry. A bright beer tank that contained a clean product for two days will require much less aggressive cleaning than a fermentation tank with a badly baked krausen ring. Moreover, a rectangular or baffled tank has to be cleaned with a device that can cover all areas that cannot be reached by a round object. In addition to that, the flow rate, pressure and number of devices have to be determined according to the tank surface area and the possible size of the CIP pump.If you're comparing options, this breakdown of CIP spray ball types sets out where each one fits, which is more useful than picking the one with the highest published flow rate.
There are two points that people tend to overlook. First, any sprayer must be designed with hygiene in mind, because if there are parts that cannot be cleaned and inspected, there is no point in having a sprayer at all. Second, one has to test for coverage rather than just assuming about it. Riboflavin testing is a time-tested method for coverage testing where the riboflavin is applied to the inner surface of a container.
The Hygienic Parts That Decide Whether CIP Works
And now the last thing custom beverage manufacturers buy, but the first thing they regret: fittings, tubes, and valves.
A sanitary fitting is a device that is intended to have its product-contact surface smooth, continuous, and devoid of cracks. Such fittings are generally connected by means of the Tri-Clamp (also known as tri-clover) method, which includes a grooved ferrule for every component, a hinged clamp band, and a food-grade gasket that is squeezed between the two. It won due to the fact that the connection does not need any tools, has no steps in the joint, and provides a smooth flow of the product.
Get the material and finish right and all the subsequent processes will be easier. The industry standard for product-contact fittings is 304 stainless steel, while 316L is used for acid-containing items or products that should remain under high temperature because its low carbon content protects it against intergranular corrosion, while the molybdenum makes it resistant to corrosion from chlorides.
The surface finish is measured in terms of Ra, and for sanitary products, the standard figure is 0.8 Ra. The general requirement for products is 0.4 Ra. Over-specifying finish leads to increase in production costs, without any benefits in terms of food safety, while the right value is dictated by hazard analysis.
Regarding tubing, it should be pointed out that tube and pipe should not be confused. Process tubing uses tube, defined by outer diameter and wall thickness and specified by such standards as ASTM A270, not pipe, specified by nominal bore. It should be noted that the diameter of tubes determines the flow rate of the product and affects the efficiency of CIP. The practical selection criteria for product lines — diameter, wall thickness, finish, and where stainless is genuinely necessary — are set out in this guide to sanitary stainless tubing in food and beverage processing, and it's worth settling before you order anything else.
First, let's talk about the valves. Butterfly valves are mostly used for on/off applications and are compact and easy to clean. Ball valves are usually used in gas, steam, and CIP applications. Diaphragm valves excel in applications where high purity and aseptic are required because this type of valve uses a flexible membrane to isolate the mechanism from the product being processed and is capable of draining completely. The only mistake to avoid is the mistake of mixing hygienic systems with non-hygienic valves because they happened to be cheap or already stocked. A regular threaded or gate valve will pass your visual inspection but fail your swab test every time.
Now let's move to gaskets. The choice of material for the gaskets has a big impact on the performance of the gaskets for many applications. For example, EPDM is used for normal water applications and for steam use, silicone gasket is used when there are concerns with temperature conditions, while PTFE is used in situations when there are aggressive chemicals processed by the valve and FKM gaskets might be used in oil and fat applications. Any gasket which starts swelling, hardening, or creating a memory will cause a problem in operation. If the same location in the plant keeps producing micro positives, usually the gasket is the culprit.
The Standards You'll Be Audited Against
Audits are not conducted measuring good practice. Audits are conducted according to specific standards and the knowledge of the correct standard makes the process top easy.
| Framework | Body | Scope | Legal weight |
|---|---|---|---|
| 3-A Sanitary Standards | 3-A Sanitary Standards, Inc. (USA) | Product-contact equipment for dairy, food and beverage; numbered standards per equipment type | Voluntary, but specified by most major retailers for new equipment |
| EHEDG guidelines | European Hygienic Engineering & Design Group | Hygienic design criteria, CIP installations, line-level cleanability; EL and EL Aseptic certification | Voluntary in law; effectively contractual for EU export |
| FDA 21 CFR Part 117 | US FDA | Current Good Manufacturing Practice and preventive controls under FSMA; equipment must be adequately cleanable | Mandatory in the US |
| ASME BPE | ASME | Bioprocessing equipment — surface finish, weld quality, materials, dimensions | Voluntary, but the default reference for high-purity work |
| ISO 14159 | ISO | Hygiene requirements for the design of machinery | Voluntary |
| EC 1935/2004 | European Commission | Food-contact materials and articles safety | Mandatory in the EU |
| GFSI schemes (SQF, BRCGS, FSSC 22000) | GFSI-recognised bodies | Prerequisite programmes that expect hygienic design, not just cleaning procedures | Contractual — required to supply most retailers |
The difference is important - “3-A certified” is not equivalent to “3-A compliant.” A certification means that the machine was evaluated according to the relevant standard by a neutral evaluator, therefore it has the right to bear the 3-A symbol. Compliance can be, and is, merely proclaimed by the manufacturer. While specifying, one should look for the symbol and the serial number.
The same reasoning can be applied to fittings and valves. The concept of hygienic design is to be treated in writing otherwise it does not have validity. If you're specifying valves for a beverage line, the questions to ask a supplier about valves that meet 3-A and ASME BPE standards are the ones that will actually get answered during an audit — material certificates, surface finish reports, seal material declarations, and a cleanability rationale.
Don't Overlook the Dispense Side
An element of beverage industry is ignored in conversations regarding sanitation and packaging; it is the dispensing and draft.
A beer system comprising of a keg coupler, a tap, a font, a piece of 3/8" beer line, and a gas regulator is a part of food contact surfaces system, just like a bottling machine. However, the process of cleaning a draft system is much less frequent than that of cleaning a bottling system. Therefore, any company engaged in supplying dispense equipment must have an option of washing equipment manufactured specifically for particular coupler systems (S, D, A, M, G), line cleaning kegs, and pressure-rated washing cups. The routine of line cleaning in a pub is once every one to two weeks using a caustic or specially developed washing chemical followed by rinsing with water or complete dismantling of the faucet after certain period of time.
The reason why we need to include it in the article about beverage packaging and sanitation is that a draft system is a packaging system at the point of sale. The keg serves as a container, the coupler is a closure, the line is a means of transportation, and the faucet is a filling device. If there are no hygienically designed fittings connecting those elements (and unfortunately very often dispense equipment is not designed that way), the whole washing process becomes a waste of time. While selecting components of dispensing systems, one should treat the criteria of the construction used in product-contact surfaces, quality of the materials, and ease of cleaning as important things rather than just marketing information.
A Practical Sanitation Checklist
The sequence discussed here is the one that matters if there’s a need for something to take into an appraisal of a plant. None of the information presented here is original; what is important is that each step must be taken in every situation.
| Area | What to verify | How often |
|---|---|---|
| Packaging — container | Preform/bottle/can rinse functioning; rinse water within spec | Every shift |
| Packaging — closure | Cap sterilisation dose verified; chemical concentration titrated | Every shift |
| Packaging — materials | Food-contact declarations current for every gasket, liner and hose | Annually and on any supplier change |
| Filler | Valve internals cleaned; bowl seals inspected; enclosure treated between products | Per CIP cycle and per changeover |
| Production — CIP | Flow velocity 1.5–2.0 m/s; chemical concentration and temperature logged; contact time met | Every cycle, recorded |
| Production — geometry | Dead legs ≤ 2–3 diameters; no undrainable low points; no unventable high points | On design and after any pipework change |
| Tanks | Spray device coverage verified (riboflavin or equivalent); device itself cleanable | On commissioning and after modification |
| Fittings and valves | Correct gasket material fitted; clamps not over-compressed; no threaded joints in product contact | At every reassembly |
| Dispense | Line cleaned to schedule; faucet stripped and rebuilt; coupler adaptors used properly | Every 1–2 weeks, plus faucet interval |
| Verification | ATP swabs, micro swabs, conductivity checks, and a documented corrective action loop | Per cleaning validation schedule |
In case you do just one thing from this list, focus on fixing geometry. This part of cleaning chemistry is reasonably grasped and easy to establish and verify. A dead leg on a pipe run installed three years ago can’t be seen, yet it continues returning occasional positive results until the dead leg itself is cut off.
Frequently Asked Questions
What does CIP mean in beverage production?
CIP is what is known as clean-in-place. Clean-in-place is a closed-loop cleaning system that employs cleaning solutions that consists of a pre-rinse, an alkaline wash, a wash rinse, an acid wash, and final sanitizing. The systems works by moving cleaning fluids using turbulence with flow rates usually around the 1.5 - 2.0 m/s range to give the shear stress required to dislodge the residue from the surfaces that come into contact with the product. The main advantage of CIP is repeatability since a predetermined cycle will allow the system to use the same settings as before which allows it to validate results unlike using conventional cleaning methods.
Is packaging sanitation or production sanitation more important?
While neither is optional, they fail in different ways. With packaging sanitation, the failure occurs specifically at the point of fill and closure, so the result of the error is usually seen in the contaminated finished product, which is very expensive. In contrast, production sanitation failures can occur upstream and intermittently, leading to the same product produced two different ways/micro results on two different days. Most plants find that packaging challenges are procedural, while production challenges are geometric, which is why equipment geometry is usually harder to fix.
What surface finish does a beverage process line need?
0.8 micrometer Ra has become a general standard for food and beverage industry products. In fact, this is roughly equivalent to No. 2B. As for the aseptic and high-care applications, including food production and pharma-related beverages, they usually require a level of polish of about 0.4 micrometer Ra. Higher polishing does not mean better quality; hence, specifying too fine a finish results in higher costs and lead time while there is no corresponding improvement in food safety; therefore, the right number is the one supported by hazard analysis or cleaning validation.
Which materials are acceptable for beverage product-contact parts?
Metals are always the basis, in which case there are 304 stainless steel for normal operation and for extreme cases 316L where the acid, the chloride or the temperature of the working liquid is concerned. Non-metal components have to be grade specific as well, such as general aqueous and steam operations EPDM, silicone for the big temperature range, PTFE for aggressive medium and FKM for fatty and oily substances. Each of these materials should be accompanied by a documented food contact declaration, as the mere declaration about “food grade” by an auditor would not suffice.
How do I know whether my line geometry is actually cleanable?
It is far better to check it than to assume anything about its content. Riboflavin testing using ultraviolet light is the most traditional coverage test in tanks and vessels, since you have to coat the insides, run the cleaning program, and examine the areas which glow. For lines, the proofs are the measurement of flow velocity during CIP, checking the conductance of the returning side of the installation, and regular sampling at joints, valves, and ends. If you notice an area that is never cleaned, the solution is most probably to change the geometry of the structure rather than to increase the concentration of the cleaning chemical.
References
- 3-A Sanitary Standards, Inc. — equipment standards and the 3-A symbol programme
- EHEDG Guidelines — hygienic design criteria and CIP installation guidance
- ASME Codes and Standards — including the Bioprocessing Equipment (BPE) standard
- NSF — third-party certification for food equipment and food-contact components
- Brewers Association — draught quality and line-cleaning guidance
- European Commission — Food Safety — food-contact materials framework under Regulation (EC) 1935/2004
- TOF USA — beverage dispensing components and cleaning adaptors
Conclusion
Beverage sanitation can be broken down into two individual components, each of which has its own failure modes. The first component is sanitation of packaging, which is sequential (e.g., rinse, disinfect, seal, and check). As a result, contamination does not become evident until the end of the production process. The second component, sanitation during the production phase, is a geometric problem, and as such, contamination may not be noticeable until later than expected, which may pose an increased risk of contamination.
The interface between the two components is hardware. The hardware used in beverage production (e.g., brackets, pipes, valves, gaskets, and spray heads) is not only an important part of the cleaning process but is also the basis for establishing the success of the cleaning process. In order for the Clean-In-Place (CIP) process to effectively clean, it must be able to reach all areas where the product flows, with a sufficient flow velocity; otherwise, disinfectants applied will not penetrate properly due to cracks, crevices, and dead areas.
Therefore, if you are designing a new beverage line or expanding an existing one, you should build your new line from the ground up around sanitary design considerations, including the type of pipe material and finish, the connection methods and design of your pipes, and other considerations before you purchase your first pump. Each of your suppliers should have the appropriate documents to demonstrate that the materials they supply for beverage production are food-grade, have been properly tested for food contact safety, and have been justified to meet sanitary requirements. If you are unable to obtain documentation from any of your suppliers, that supplier should be considered a poor choice.
