Glossary

ADA – American Diabetes Association: It is a US based for-profit organization that seeks to educate the public about diabetes and help those affected by funding research to control, cure, and prevent diabetes.

AFFS – Aseptic Form-Fill-Seal: An advanced FFS technology used in the pharmaceutical industry to produce sterile unit-dose vials and ampoules, maintaining aseptic conditions throughout the packaging process.

AKI – Acute Kidney Injury: Acute Kidney Injury is when the kidneys suddenly stop working properly.

ANVISA – The National Health Surveillance Agency: The National Health Surveillance Agency is an autonomous regulatory body of the Brazilian government.

APD – Automatic Peritoneal Dialysis: It is an at-home treatment that can be done overnight.

APF – Advance Print Foil: Hot stamping/printing film is a foil used in printing the labels on IV bags by transferring ink to a surface at high temperatures.

API – Active Pharmaceutical Ingredient: Biologically active drug component, responsible for therapeutic effects. Formulated with excipients for final dosage form. Strict regulations ensure quality.

Aseptic: Refers to absence of pathogens. When it comes to IV- packaging, one may hear Aseptic filling frequently. This refers to a process where the container is sterilized before filling of IV-solution under cleanroom or sterile environment.

Autoclave – Steriliser /Autoclave cabinet: The sterilizing of equipment and supplies used before surgical procedures by subjecting them to pressurized saturated steam at 121 °C.

Automatic FFS – Automatic FFS Machines: Highly automated equipment used for FFS packaging, capable of performing the entire process, including material feeding, forming, filling, and sealing, with minimal human intervention.

Bagmaker: Machine for production of infusion bags. Alternative to FFS process where the production is fully integrated. Some products need premade bags that are filled afterwards in a separate Filler.

BFS – Blow Fill Seal: A technology as alternative to FFS machines, using a blow mold to form, mainly rigid or semi-rigid plastic container.

Bioburden: Describes the measure of viable microorganisms associated with a specific item before sterilization.

Bioprocessing: The use of biological systems, such as cells, enzymes, or microorganisms, to produce biopharmaceuticals or other valuable products through fermentation, cell culture, and purification techniques.

Blown Film: Refers to a plastic film that is produced via blown film extrusion, also known as film blowing process. The molten polymer is extruded through an annular die, which is inflated into a bubble by blowing air inside. The bubble is then cooled down and collapsed via rollers to create a flat film.

CAPD – Continuous Ambulatory Peritoneal Dialysis: It refers to a dialysis method where the filtration of the blood happens inside of the body using Peritoneal Membrane. CAPD is a manual process, where the gravity does the filling and draining of the dialysate inside the peritoneum, instead of a machine.

Cast Film: Refers to a plastic film that is produced via cast film extrusion method. In this method the molten polymer is extruded through a flat die system to adopt its final flat shape and cooled down afterwards.

CDE/NMPA: Registration standard for imported pharmaceutical packaging materials

CFDA – China Food and Drug Administration: Now NMPA. Directly under The State Council, the CFDA is a drug supervision and administration department set up by the national government.

CKD – Chronic Kidney Disease: A long-term condition where kidneys are damaged and unable to filter blood effectively, leading to gradual loss of kidney function.

cleanroom: A controlled environment where pollutants like dust, airborne microbes, and aerosol particles are filtered out to provide the cleanest area possible. Most cleanrooms are used for manufacturing products such as electronics, pharmaceutical products, and medical equipment.

CMO – Contract Manufacturing Organization: Provides manufacturing services to pharma companies under contractual agreements. Outsourcing benefits and specialization.

COA – Certificate of Analysis: A product’s certificate of analysis (CoA) is a crucial document mostly performed on chemical products and details all the testing carried out on it before the shippment to a customer.

COF – Coefficient of friction: A physical index of plastic film.

CRO – Contract Research Organization: A company that manufactures products for pharmaceutical or biotechnology companies under a contractual agreement.

CSTD – Closed System Transfer Device: A specialized device used to safely transfer hazardous drugs between containers, preventing exposure and contamination during handling.

Customization – Customized IV Bag Sizes: IV bags available in various sizes to accommodate different fluid volumes and dosage requirements.

Cytostatics: Cytostatics are drugs primarily used in cancer treatment in the field of Oncology. These drugs interfere with cell division in different ways targeting especially those cells that are growing very fast.

DEHP – Di(2-ethylhexyl) phthalate: A manufactured chemical.

Delamination: It is a defect of a material consisting of the separation/fracture of its layers. It does not happen to our film as it is co-extruded.

Dialysis: The process of removing excess water, solutes, and toxins from the blood in people whose kidneys can no longer perform these functions naturally. This is also referred to as renal replacement therapy.

Dialysis Fluid: A sterile solution infused into the peritoneal cavity during CAPD, containing electrolytes and glucose that facilitate the exchange of waste and excess fluids across the peritoneal membrane.

DMF – Drug Master File: Confidential submission to authorities with manufacturing details, supporting drug’s safety and quality.

Enteral – Enteral Nutrition: Delivery of nutrients via tubes.

EP – European Pharmacopoeia: It is the only guiding document for drug quality testing in Europe. Manufacturers of all medicinal products and medicinal substrates must comply with the quality standards of the European Pharmacopoeia in their marketing and use within Europe.

ESKD – End-Stage Kidney Disease: Final stage of kidney failure, requiring dialysis or kidney transplant for survival.

ESRD – End-Stage Renal Disease: Advanced and permanent kidney failure requiring dialysis or kidney transplant for survival.

ETO – Ethylene Oxide Sterilization: A sterilization method using ethylene oxide as a medium for sterilization. 6,PP (58):Polypropylene It is a thermoplastic resin made by polymerization of propylene. Three types of isotactic polyprolene, atactic polypropylene , and syndiotactic polypropylene were selected according to their methyl group placement.

EVA – Ethylene Vinyl Acetate: A copolymer used in IV-bag packaging for its flexibility, clarity, and compatibility with a wide range of sterile liquids.

Exchange – Cycle ( CAPD ): The process of infusing fresh dialysis fluid into the peritoneal cavity and draining used fluid out during CAPD, typically performed multiple times a day.

Extractables – Extractables: Extractables are compounds that migrate from a material in contact with the product when exposed to the appropriate solvent under well-defined extreme conditions of time and temperature.

extruder: Extruders are industrial machines that apply pressure to solid and viscous materials to force their passage through a nozzle opening. This process is called extrusion.

Extrusion: The primary manufacturing process for IV films is extrusion, where the plastic resins are melted and forced through a die to create a continuous flat sheet of the desired thickness.

F0/Fzero: The F-value indicates the sterilization times at a constant temperature. This means the F-value is expressed in minutes at a specific temperature. The sterilization time for reaching a certain final bacterial count can be calculated at a given F0 value will be validated at a sterilization temperature of 121°C and heating / cooling phase. Validation is described for example in ISO 11737-2

FDA – The Food and Drug Administration (United States): It is a confidential document submitted to the FDA by the supplier of an active drug substance or packaging material. It includes detailed information about the equipment, process, and materials used in the manufacturing, processing, packaging, and storage of the drug.

FFS – Form Fill Seal: A process of bagforming “F” where the goods are also filled “F” into the container and sealed “S” afterwards in a fully automated machine. It’s the most widely used process for the production of infusion bags.

Filler – Filling Machine for IV bags: They are available as small Table top equipment for trials & small batch production but also as semi-automatic machines where an operator just inserts a premade bag and the machine does automated filling and closing. Such filling machines use premade bags produced on a bagmaker.

Formulation: During extrusion, additional additives and stabilizers may be incorporated into the plastic to enhance properties such as clarity, flexibility, and resistance to punctures or tears.

Gas Barrier: IV films prevent oxygen, moisture, and other gases from entering or leaving the bag, preserving contents’ quality and stability, vital for oxygen-sensitive medications.

GMP – Good Manufacturing Practice: Ensures high-quality production of healthcare products, adhering to safety, efficacy, and purity standards.

HDPE – High Density Polyethylene: High-density polyethylene is a thermoplastic made up of a string of ethylene molecules. It is produced at low pressure with high crystallinity, melting point and density.

Heat-Sealed IV Bags: IV bags sealed using heat or ultrasonic welding to maintain a sterile barrier and prevent contamination.

Hemodialysis – Artifical Blood Purification: In this process, blood is cleaned with the aid of a dialyzer, in which the blood flows along a thin membrane and, by diffusion, delivers all the toxins into a highly pure water-salt solution.

Intravenous Nutrition: Total parenteral nutrition (TPN) or peripheral parenteral nutrition (PPN) is administered through IV infusions to provide complete nutrition when oral intake is not possible.

Irrigation Solution: These are colorless solutions kept in containers made of plastic. The irrigation is typically used by medical professionals to cleanse and wash body cavities, tissues, or wounds. Typically utilized in the areas of gynecology, orthopedics, urology, and accident surgery.

ISO – International Organization for Standardization: International organization for developing global standards ensuring quality and safety in various industries, including pharmaceuticals.

ISO 10993: Biological Evaluation of medical devices

ISO 15747: Plastics containers for intravenous injection

IV – Intravenous injection: Administering a substance directly into a vein using a syringe or infusion, allowing rapid absorption and immediate systemic effects.

IV Flow Rate: The rate at which an IV fluid is administered into a patient. In order to estimate the precise dosage of fluids or medication a patient requires, nurses will calculate the IV flow rate.

LDPE – Low Density Polyethylene: LDPE is a thermoplastic that is flexible and tough. It has low crystallinity and melting point. Compared to HDPE it has more branching so its intermolecular forces are weaker, its tensile strength is lower, and its resilience is higher.

Leachables: Leachables are chemical species, both organic and inorganic, that can be released from the surfaces of components used in the production and storage of pharmaceutical products and enter the product under typical use conditions.

Light-Protected IV Bags: IV bags with light-protective materials or layers to shield light-sensitive medications or solutions from degradation.

LVP – Large Volume Parenteral: A sterile, injectable solution packaged in containers with volumes greater than 100 milliliters, used for intravenous administration.

MCB – Multi Chamber Bag: Often comprised of two and three chambers, separated by a peel weld. For application the peel weld has to be opened by pressing one of the chambers. These IV bags contain macronutrients that can be mixed and administered to the patients via IV. These IV bags are designed primarily for people who need intravenous nutrition and typically require a full spectrum of nutrients

MCB-PN – Multi Chamber Bag-Parenteral Nutrition: A specialized medical bag containing separate compartments for different parenteral nutrition components, enabling safe and convenient mixing before administration.

MFI – Melt Flow Index: A measure of flow resistance of melted plastic at a given temperature, for a duration of time, under a given force. MFI is expressed in grams of polymer per duration of 10 minutes of flow, with values calculated at g/10 min. It is often used in the plastic industry for quality control of thermoplastics.

Moisture Barrier: IV films with low moisture transmission rates prevent moisture absorption or loss from the bag’s contents, ensuring product stability and preventing microbial growth or chemical degradation.

Multi-Layer – Multi-Layer Barrier Films: Specialty plastic films used in FFS packaging with multiple layers to provide enhanced barrier properties against oxygen, moisture, and light, protecting the product’s stability and shelf life.

NaCl – Sodium Chloride: Provides sodium and chloride ions to maintain electrolyte balance and cellular function.

NDA – New Drug Application: Formal submission to regulators with data on new drug’s safety, efficacy, seeking approval for marketing.

NMPA – National Medical Products Administration: Same to CFDA, in 2018, CFDA changed its English name to National Medical Products Administration.

NS – Normal Saline: A solution of 0.9% sodium chloride (NaCl) in water, used for medical purposes, such as intravenous hydration and as a diluent for medications.

Parenteral – Parenteral Nutrition: Intravenously feeding, on the outside of the digestive tract.

PD – Pharmacodynamics: Pharmacodynamics is the body’s biological response to drugs.

PE – Polyethylene: A versatile polymer made from ethylene monomers, commonly used in various applications, including packaging, plastic bottles, and medical devices.

Pediatric Formulations: Medications tailored for children with appropriate dosing and age-specific formulations.

Peel-Siegel – Peel Seal in IV-Beuteln: Originalitätsverschluss für den sterilen Zugang; beim Öffnen des Beutels wird festgestellt, ob er geöffnet oder manipuliert wurde, wodurch die Unversehrtheit des Produkts gewährleistet wird.

Peritoneal Dialysis – Blood Purification: Pumping dialysis fluid into the area inside the abdomen to pull out excess products from the blood. This treatment ensures permanent blood purification and can be done at home, or at an outpatient facility.

Peritoneum – A Membrane: A membrane lining the insides of the abdomen and pelvis.

Peritonitis – Gastrointestinal Disease: A severe life-threatening condition

PET – Polyethylene Terephthalate: A common thermoplastic polymer used in IV-bag packaging due to its transparency, strength, and compatibility with sterile liquids.

PK – Pharmacokinetics: Pharmacokinetics is the movement of drugs through the body

PP – Polypropylene: It is a thermoplastic resin made by polymerization of propylene. Three types of isotactic polyprolene, atactic polypropylene , and syndiotactic polypropylene were selected according to their methyl group placement.

Pre-Filled – Pre-Filled IV Bags: IV bags filled with medications or solutions in a ready-to-use form, reducing preparation time and the risk of dosing errors.

Premixed – Ready-Made Formulations: A premixed formulation for ready-made parenteral nutrition delivery system.

Printed Film – Printed IV Bags: IV bags with printed labels, instructions, or drug-specific information for easy identification and compliance.

PVC – Polyvinyl Chloride: A synthetic thermoplastic polymer composed of vinyl chloride monomers, widely used in construction, healthcare products, and packaging due to its versatility and durability.

PVC-Free – PVC-Free IV Bags: IV bags made without polyvinyl chloride (PVC), addressing concerns about potential leaching of PVC-related additives.

QA – Quality Assurance: It refers to all planned and systematic activities implemented in the quality system and verified as needed in order to provide sufficient trust to show that the enterprise can meet the quality requirements.,

QC – Quality Control: The part of quality management devoted to meeting quality requirements. Now refers to enterprise inspection and release.

Reconstitution: Restoring powdered medication or vaccine to liquid form by adding sterile diluent for administration.

Ringer’s Solutions – Ringer’s lactate solution: An isotonic electrolyte solution used in medical settings for fluid and electrolyte replacement

RTA – Ready to Administer Drugs: Pre-packaged and ready for immediate administration without additional preparation.

Sealing Properties: IV films must possess appropriate sealing properties to facilitate the formation of a hermetic seal during IV bag assembly.

Septicemia – Sepsis: Bacteria poisened blood.

SFDA – State Food and Drug Administration: It is directly under The State Council to supervise and administer the food safety of drugs, medical devices, cosmetics, health food and catering links.

Single Chamber – Single Chamber IV Bags: Traditional IV bags with a single chamber used for administering fluids, medications, and electrolyte solutions.

Sterilization Compatibility: IV films must be compatible with common sterilization methods used in the medical industry, such as gamma irradiation or ethylene oxide (EtO) sterilization.

SUS – Single Use System: Disposable equipment or components designed for one-time use to prevent cross-contamination and simplify cleaning and sterilization processes.

SUS Bags – Single-Use Bags and Containers: Disposable bags and containers used for storage, transport, and handling of media, buffers, and process intermediates in bioprocessing.

SVP – Small Volume Parenteral: Sterile injectable solutions packaged in containers with volumes typically less than or equal to 100 milliliters, used for intravenous administration.

Tensile Strength: It is the capacity that the plastic material has when we stretch it without failure, which means to know the maximum amount of tensile stress the material has.

Thermoforming – FFS Technology: A process in the FFS technology where a plastic film is heated and then shaped using a mold to create the desired container or cavity for the product.

TPN – Total Parenteral Nutrition: Intravenous feeding. Total parenteral nutrition does not pass through the digestive system. This type of feeding is given to a person who is unable to absorb nutrients in the intestine due to certain diseases, or health conditions.

TPN Bag: A specialized IV bag containing a sterile solution with all the necessary nutrients, vitamins, minerals, amino acids, and lipids required for the patient’s nutrition during TPN therapy.

Unit Dose Packaging: FFS packaging that individually separates and seals a single dose of a product, ensuring accurate dosing and convenient dispensing, commonly used for medications in healthcare settings.

USP – United States Pharmacopoeia: It is a technical regulation of the quality standards and verification methods of drugs made by the United States government. It is also the legal basis for the production, use, management and testing of drugs.

Validation: A term in Pharma industry that describes a process of creating documentation-supported evidence that shows practices, processes, or actions carried out in manufacturing maintain the necessary degree of compliance and achieve measurable results

Ventilation – Ventilation (of IV-bags): Ventilation of IV-bags is the foreign air needed to empty the container by a vent cap. For bottles = needed For bags = not needed / no contamination Risk