Analysis Of PFS

PFS (6)

What is PFS?

PFS, Pre-Filled Syringe.

In 1981, Becton Dickinson of the United States invented the first pre-filled syringe.

In 1997, pre-filled syringe entered the Chinese market.

Purpose: packaging and storage of high-grade drugs, and directly used for injection or washing in ophthalmology / otolaryngology / orthopedics / surgery.

Filling materials: suspensions (insoluble, solid separated from two solutions, slow release), emulsifying (chemical) agents (insoluble liquid), liposomes (micro vesicles formed by drug encapsulated in lipid bilayer: targeting, slow release, toxicity reduction, and drug protection), nanoscale suspensions.
Customer groups: medical beauty manufacturers, high-end drug manufacturers, vaccine manufacturers, biopharmaceuticals.

Why we choose PFS?

Advantages of PFS
Pre-filled syringe can be used for patients who are not suitable for oral medication.
Rapid and reliable effect.
Pre-filled syringe can be used for drugs not suitable for oral use.
Pre-filled syringe can be used to inject nutrients.
Local positioning.
No secondary pollution: air contact, glass damage, solid particles, drug waste, inaccurate dose
The medical staff is simple, convenient and timely to use.
The manufacturing enterprise saves the tedious procedure of clear packaging containers.
Customer sales end: high-end and upscale.

Disadvantages of PFS
Inconvenient injection: pain.
The wrong dose of injection may cause irreversible injury.
High quality requirements: sterilization method, strict production process control (environment, personnel, materials).
High upfront investment cost.

Trend of PFS development
1. Replace the use of ampoule bottle and penicillin bottle (Lenovo: our penicillin bottle/ampoule bottle customers finally come here).
2. The future sterile production process will use more moist heat sterilization: more stable sterilization cabinet, better packaging materials.
3. PRTC: Plastic Rigid Tip Cap (with luer locking joint) is applicable to materials with high viscosity, such as hyaluronic acid.
CCT: LUER vertebral head type LLA: LUER screw type
From CCT to LLA to PRTC
Problem: Glass is easy to break, so it tends to use COC/COP (new cyclic olefin copolymer). Not easy to break, high heat resistance, water absorption, water permeability, biocompatibility, low absorption, environmental protection.
The concept of coated rubber plug: whether it will react with materials, whether it is worn when plugging, and whether foreign matters are generated.

PFS composition, process and personnel requirements

Composition and process of PFS system: non-final sterilization, final sterilization
A. Non-final sterilization (see figure): weighing, liquid preparation, sterile filtration, unpacking, unpacking (paper tearing Tyvek), filling and plugging, testing, labeling and packaging

B. Final sterilization (see figure): weighing, liquid preparation, sterile filtration, unpacking, unpacking (paper tearing Tyvek), filling and plugging, sterilization, testing, labeling and packaging

**Packaging material sterilization: ethylene oxide sterilization, γ Radiation sterilization
PFS personnel requirements: personnel are the largest source of pollution, so it is necessary to control personnel hygiene, number of workshop personnel, changing control, personnel microbial monitoring (sampling), and SOP.
***Safety requirements

Selection of filling equipment

Equipment classification: semi-automatic, beehive type (glass), straight/runway type (4/6/8/10 heads, plastic), rotary type (single head/double head, glass/plastic).
Material classification:
Glass: vacuum filling and plugging.
Plastic: bottom filling (assembled), purple filling plus filling plus plug plus rotating rod.
Filling form classification: normal pressure filling, positive pressure filling, negative pressure filling (glass, high viscosity, vacuum).
RABs system: laminar flow hood, oRABS, cRABS, Isolator.

What determines the quality of filling equipment?

Tightness, loading, foreign matter, bubble, skew plug.
The problem of bubbles in filling (air residue): the size of bubbles depends on the vacuum degree and filling liquid level, boiling point (boiling point in negative pressure decreases, water 10mBar/9 ℃), rubber plug displacement (temperature change during sterilization, transportation and storage), which can be invisible to the naked eye (molecules still exist), rubber plug release force: 2N, and bubble compressibility.
Bubble paradox: the advantage is to facilitate thermal sterilization, adapt to the pressure and temperature changes during air transportation, and fix the rubber plug; The disadvantage is that the material is oxidized, unsightly and the rubber plug is displaced. Therefore, the pharmaceutical factory needs to calculate the minimum bubble size to avoid displacement of the rubber plug.
Summary: PFS material, use, material characteristics, output, customer testing.

manufacturers

Domestic manufacturers
Dongfulong: glass tube, automatic beehive type.
LTPM: Semi-automatic, straight (4/6/8/10), glass tube, automatic beehive type.
Chutian: glass tube, automatic beehive type.

Foreign manufacturers
OPTIMA, Bosch, IMA.