When you enter the water bottling business you will be required to observe a wide variety of regulations imposed by governmental authorities at the local, state and sometimes federal level. Your bottled water will be produced for public consumption and you will be required to bottle it in a sanitary environment. This means you will need what is called a "cleanroom".
State and local health officials frown on water bottling activities which are not conducted within the confines of an appropriate cleanroom. In most cases, they have the authority to revoke business licenses, impose fines and "redtag" buildings and facilities if they are found to be deficient in this respect.
This is an important aspect of your bottling activity - do not underestimate the importance of this issue.
A cleanroom contains all of the equipment in the bottling activity which would expose the product water and the container(bottle) to any biological or inorganic contaminant. In the above picture, the blowmolded PET bottle is fed into the cleanroom through a "pass through" access port. Inside the cleanroom, the bottle is rinsed, filled, labeled and capped and then fed through a"pass through" exit port to the packaging area.
A cleanroom can take on many forms; from that of the bottling industry in the current discussions to nutraceuticals, pharmaceuticals and on into the semiconductor and electronics industries. Each industry requires a different level or classification of cleanroom sanitation with the bottling system at the "easiest" level and normally the high technology electronics and biosciences activites in the most stringent cleanroom environments.
Classification of Cleanrooms and Cleanroom Standards
Different areas and governmental jurisdictions may require different types or classifications of cleanrooms. Cleanrooms in one part of the US or one country may be different than the next. Check with your local health or inspection authority to determine what classification applies in your area. The following information will help sort out what all of these classifications mean, which one may apply to you and what type of construction and features will provide compliance with the classification for your specific operation.
Cleanrooms are classified by the cleanliness of their air. The method most easily understood and universally applied to US facilities is Federal Standard 209D in which the number of particles equal to and greater than 0.5 micrometers is measured in one cubic foot of air and this count is then used to classify the room. International and possibly future US facilities will follow ISO standards which are also summarized below.
FS-209D was first published in 1963 in the USA and titled "Cleanroom and Work Station Requirements, Controlled Environments". It has gone through various revisions since then and is available from
Institute of Environmental Sciences
940 East Northwest Highway
Mount Prospect, IL. 60056.
0101 - 708- 255-1561
FEDERAL STANDARD 209D CLEANROOM CLASS LIMITS
CLASS MEASURED PARTICLE SIZE(MICROMETERS) 0.1 0.2 0.3 0.5 5.0 1 35 7.5 3 1 NA 10 350 75 30 10 NA 100 NA 750 300 100 NA 1,000 NA NA NA 1,000 7 10,000 NA NA NA 10,000 70 100,000 NA NA NA 100,000 700
Sometimes FS-209D is defined in metric values; this regulation is FS-209E and is available from the US General Service Administration(GSA) and is entitled: "Airborne Particulate Cleanliness Classes in Clean Rooms and Clean Zones".
If you are building a bottling plant overseas and are governed by International Standards Organization(ISO) requirements, another document applies: ISO 14644-1"Cleanrooms and Associated Controlled Environments Part 1: Classification of airborne particulates". The conversion between various ISO classes and FS209D is shown in the table below.
AIRBORNE PARTICULATE CLEANLINESS CLASS COMPARISON
ISO 14644-1 FED STD 209E ISO Class English 1 - 2 - 3 1 4 10 5 100 6 1,000 7 10,000 8 100,000 9 -
If you are building to an ISO standard you will require fewer sample locations for facility certification, especially as the cleanroom size increases; however, the ISO standard does require minimum one minute air samples, whereas the Federal Standard allows shorter samples, especially at smaller particle sizes. Periodic resampling is required(say 6 months to 12 month intervals) to maintain compliance with ISO or FS. Some 35 countries currently are active in promoting ISO standards for cleanrooms.
For reference purposes, the voting members of the committee responsible for establishing ISO standards and practices are: Australia, Belgium, China, Denmark, Finland, France, Germany, Italy, Jamaica, Japan, Korea, Netherlands, Norway, Portugal, Russia, Sweden, Switzerland, the UK and the United States. Nonvoting members include Bulgaria, the Czech Republic, Egypt, India, Ireland, Malaysia, New Zealand, the Philippines, Poland, Saudia Arabia, South Africa, Thailand, Turkey, Ukraine and Yugoslavia.
If you are building in any of these countries you will probably be governed by ISO standards and procedures; other countries can follow FS-209. A wide range of ISO documents should be available in your host country describing everything from operations, design, terms, definitions, testing, evaluation methods, biocontamination and so forth.
Cleanroom Design Criteria
Once you determine the classification of your cleanroom, the construction, type of materials and air circulation system are specified by way of the appropriate FS or ISO standard. Bottling systems will usually fall under the 100,000 or 10,000 FS category(normally 100,000). The design criteria for these two categories are summarized below. Category 10,000 cleanrooms usually are for injectables or high purity nutraceuticals or some pharmaceuticals.
CRITERIA CLASS 10,000; M5.5 OR ISO 7 CLASS 100,000; M6.5 OR ISO 8 Air changes per hour/min 60/1 36/0.6 Filter Coverage(%) 7 to 15 4 to 5 CFM per square ft 9 to 16 5 to 8 Filter efficiency 99.997%(4-9s HEPAs) 99.97%(3-9s HEPAs) Type of Ceiling Conventional "T" grid, gasketed Light Fixture Type 2' x 4' Clean Room Fixture 2' x 4' Standard Fixture(field sealed) Ceiling Panels Vinylrock or Mylar Wall System Modular Modular or Drywall Floor Covering Sheet Vinyl or VCT Flooring Base Cove or Top Set Base Air Returns Low Wall Low Wall or Ceiling
The following pictures illustrates typical interiors of 100,000 class cleanrooms. Note floor, wall and ceiling compliance with above table.
Filtered air flow in a "tight" cleanroom can be as shown at right below. In most cases, there will be entry and exit "flaps" where bottles enter and exit the cleanroom; that is where most filtered(exhaust) air will exit.
Ceiling filters should be sized to the total volume of the cleanroom and the "turnover" of air as noted in the table above. These filters are usually ceiling mounted. Most small bottling operations will require only a single ceiling air filter as illustrated below left.
Obviously, more elaborate(and expensive) cleanrooms can be constructed. Some bottling facilities are "visitor friendly" and allow for a wider view of the interior operations. Some of these are illustrated below.
A typical small format bottling operation is laid out below, illustrating the various components, their size and location inside and outside of the required cleanroom.
The design illustrated below includes a 21' x 12' x 10' cleanroom. It will accommodate the Spectrapak 3000 Bottling System.
A 12' x 32' x 10' cleanroom will accommodate a typical, turnkey Spectrapak 5000 Bottling System as illustrated in the scale drawing below.
Should you decide to have us assist you in building water bottling equipment for your facility, we can then work with you to identify obtain all the necessary cleanroom construction components to fit the equipment you plan to enclose in the cleanroom.
General Cleanroom Regulations
Below is a list of general regulations recommended as a minimum for the successful operation of a cleanroom. All professional cleaning personnel should be aware and follow these regulations at all times.
1. All personal items such as keys, watches, rings, matches, lighters and cigarettes should be stored in the personal locker outside the gowning room.
2. Valuable personal Items such as wallets may be permitted in the cleanroom provided they are NEVER removed from beneath the cleanroom garments.
3. NO eating, smoking or gum chewing allowed inside the cleanroom.
4. Only garments approved for the cleanroom should be worn when entering.
5. NO cosmetics shall be worn in the cleanrooms. This includes: rouge, lipstick, eye shadow, eyebrow pencil, mascara, eye liner, false eye lashes, fingernail polish, hair spray, mousse, or the heavy use of aerosols, after shaves and perfumes.
6. Only approved cleanroom paper shall be allowed in the cleanroom.
7. Approved ball point pens shall be the only writing tool used.
8. Use of paper or fabric towels are prohibited. Use of hand dryers equipped with HEPA filters are suggested.
9. Gloves or finger cots should not be allowed to touch any item or surface that has not been thoroughly cleaned.
10. Only approved gloves, finger cots (powder-free), pliers, tweezers should be used to
handle product. Finger prints can be a major source of contamination on some products.
11. Solvent contact with the bare skin should be avoided. They can remove skin oils and increase skin flaking.
12. Approved skin lotions or lanolin based soaps are sometimes allowed. These can reduce skin flaking.
13. All tools, containers and fixtures used in the cleaning process should be cleaned to the same degree as the cleanroom surfaces. All of these items are a source of contamination.
14. NO tool should be allowed to rest on the surface of a bench or table. It should be place on a cleanroom wiper.
15. Only cleanroom approved wipers are allowed to be used. The wipers must be approved for the Class of cleanroom being cleaned.
16. ALL equipment, materials and containers introduced into a sterile facility must be subjected to stringent sterilization prior to entrance.
17. NO ONE who is physically ill, especially with respiratory or stomach disorders, may enter a sterile room. This is a good practice in any cleanroom environment.
Personal Actions Typically Prohibited in Cleanrooms
1. Fast motions such as running, walking fast or horseplay.
2. Sitting or leaning on equipment or work surfaces.
3. Writing on equipment or garments.
4. Removal of items from beneath the cleanroom garments.
5. Wearing the cleanroom garment outside the cleanroom.
6. Wearing torn or soiled garments.
REMEMBER, TO A GREAT EXTENT, THE QUALITY OF YOUR BOTTLED WATER PRODUCT IS ONLY AS GOOD AS THE INTEGRITY OF YOUR CLEANROOM!
A good place for you to start if you are just beginning the process of defining your water bottling operation is HERE where a series of interactive questions will allow us to assist you in this effort.
For additional information, contact Gene Shaparenko at 1-805-773-4502 or you can reach us at firstname.lastname@example.org
FOR ADDITIONAL INFORMATION ON OTHER BOTTLING COMPONENTS SHOWN IN THE CAD SCALE DRAWINGS ABOVE AND THE ARTIST CONCEPT ILLUSTRATION AT THE TOP OF THIS PAGE, CLICK ON THE FOLLOWING LINKS: