ᱪᱮᱫ ᱠᱚ ᱫᱚ ᱯᱟᱨᱤᱵᱮᱥᱵᱷᱟᱨ ᱞᱟᱹᱜᱤᱫ ᱞᱟᱹᱠᱛᱤᱭᱟᱱ ᱫᱟᱲᱮ ᱠᱚ ᱞᱟᱹᱜᱤᱫ ᱠᱟᱱᱟ?

ᱢᱮᱴᱨᱤᱠ ᱨᱮᱭᱟᱜ ᱫᱟᱲᱮ ᱫᱚ ᱥᱟᱹᱨᱤ ᱟᱨ ᱫᱟᱲᱮ, ᱵᱮᱵᱷᱟᱨ, ᱫᱟᱲᱮ, ᱟᱨ ᱠᱟᱹᱢᱤ ᱦᱚᱨᱟ ᱨᱮᱭᱟᱜ ᱵᱮᱵᱷᱟᱨ ᱠᱚ ᱨᱮᱭᱟᱜ ᱢᱤᱫ ᱥᱮᱬᱟ ᱦᱤᱥᱟᱹ ᱠᱟᱱᱟ᱾ ᱪᱮᱫᱟᱜ ᱥᱮ ᱢᱤᱫ ᱵᱟᱹᱲᱤᱡ, ᱵᱟᱹᱲᱤᱡ ᱟᱨ ᱵᱟᱹᱲᱤᱡ ᱠᱟᱹᱢᱤ ᱠᱚ ᱫᱚ ᱟᱹᱰᱤ ᱵᱮᱥ ᱛᱮ ᱛᱟᱦᱮᱱ ᱠᱟᱱᱟ, ᱚᱱᱟ ᱛᱮ, ᱱᱚᱶᱟ ᱫᱚ ᱟᱹᱰᱤ ᱵᱮᱥ ᱛᱮ ᱛᱟᱦᱮᱱ ᱠᱟᱱᱟ, ᱚᱱᱟ ᱫᱚ ᱵᱟᱝ ᱵᱟᱰᱟᱭ ᱧᱟᱢ ᱞᱟᱹᱜᱤᱫ ᱠᱟᱱᱟ᱾ ᱱᱚᱶᱟ ᱫᱚ ᱟᱹᱰᱤ ᱡᱟᱹᱨᱩᱲ ᱜᱮᱭᱟ, ᱡᱟᱦᱟᱸ ᱨᱮ ᱦᱚᱲ ᱠᱚ ᱫᱚ ᱥᱚᱱᱜᱚᱛᱷᱟᱱ ᱠᱚ ᱵᱮᱵᱚᱦᱟᱨ ᱠᱟᱛᱮ ᱠᱚ ᱠᱟᱹᱢᱤ ᱠᱟᱱᱟ, ᱟᱨ ᱚᱱᱟ ᱠᱚ ᱫᱚ ᱟᱹᱰᱤ ᱵᱮᱥ ᱞᱮᱠᱟ ᱛᱮ ᱵᱮᱵᱚᱦᱟᱨᱚᱜ ᱠᱟᱱᱟ, ᱟᱨ (Pables) ᱠᱚ ᱫᱚ ᱟᱹᱰᱤ ᱵᱮᱥ ᱠᱚ ᱠᱟᱹᱢᱤ ᱠᱟᱱᱟ᱾

1. ᱵᱞᱚᱠᱪᱮᱭᱱ: ᱢᱟᱭᱠᱨᱚᱥᱠᱳᱯᱤᱠ ᱟᱨ ᱠᱚᱱᱴᱨᱚᱞ ᱜᱟᱫᱮᱞ ᱠᱚ ᱛᱟᱞᱟ ᱨᱮ ᱾

ᱢᱮᱴᱨᱤᱠᱥ ᱫᱚ ᱥᱟᱱᱟᱢ ᱠᱷᱚᱱ ᱵᱮᱥ ᱛᱮ ᱵᱮᱱᱟᱣ ᱟᱠᱟᱱ ᱢᱮᱴᱨᱤᱠᱥ ᱨᱮᱭᱟᱜ ᱢᱤᱫ ᱢᱩᱲᱩᱫ ᱫᱷᱟᱯ ᱠᱟᱱᱟ ᱾ According to GMP standards, non-sterile empty capsule filling is typically conducted in a Grade D clean area, requiring no more than 3,520,000 airborne particles>=0.5μm per m³ and settling microbes no more than 200 CFU/plate. For sterile capsules, filling must be performed in a Grade A unidirectional flow environment within a Grade D background, with airborne particles no more than 3,500 per m³ and settling microbes no more than 1 CFU/plate. Clean areas must be purified by a three-stage air filtration system (pre-, medium-, and high-efficiency) and regularly tested for indicators such as airborne particles, floating microbes, and settling microbes to ensure continuous compliance, preventing microbial and particulate contamination of capsules and drugs.

2. ᱠᱚᱱᱴᱨᱚᱞ ᱟᱨ ᱜᱞᱩᱠᱚᱡᱽ ᱟᱨ ᱜᱞᱩᱠᱚᱡᱽ: ᱜᱞᱩᱠᱚᱡᱽ ᱨᱮᱭᱟᱜ ᱥᱯᱤᱰ ᱟᱨ ᱚᱯᱴᱤᱢᱟᱭᱡᱮᱥᱚᱱ᱾

ᱜᱞᱩᱠᱚᱡᱽ ᱨᱮᱭᱟᱜ ᱞᱚᱞᱚ ᱫᱚ ᱢᱤᱫ ᱢᱟᱨᱟᱝ ᱢᱮᱴᱨᱤᱠᱥ ᱠᱟᱱᱟ, ᱡᱟᱦᱟᱸ ᱫᱚ ᱥᱤ ᱟᱨ ᱥᱤ ᱨᱮᱭᱟᱜ ᱠᱟᱹᱢᱤ ᱠᱟᱱᱟ ᱾ ᱠᱚᱢ ᱠᱷᱚᱱ ᱠᱚᱢ ᱵᱟᱹᱲᱛᱤ ᱫᱟᱲᱮ ᱫᱚ ᱵᱟᱝ ᱦᱩᱭᱩᱜ ᱠᱟᱱᱟ, ᱚᱱᱟ ᱛᱮ ᱜᱞᱩᱠᱚᱡᱽ, ᱟᱨ ᱵᱟᱝ ᱠᱷᱟᱱ ᱮᱴᱟᱜ ᱠᱚ ᱫᱚ ᱵᱟᱹᱲᱛᱤ ᱠᱚ ᱵᱟᱹᱲᱤᱡ ᱫᱟᱲᱮᱭᱟᱜ-ᱟ᱾ ᱚᱱᱟ ᱚᱠᱛᱚ ᱨᱮ, ᱞᱚᱞᱚ ᱟᱨ ᱯᱨᱚᱵᱷᱟᱣᱟᱱ ᱡᱤᱱᱤᱥ ᱠᱚ ᱫᱚ ᱞᱚᱞᱚ ᱟᱨ ᱵᱟᱝ ᱵᱮᱥ ᱞᱮᱠᱟᱛᱮ ᱮᱥᱮᱨᱚᱜ-ᱟ ᱾ ᱚᱱᱟ ᱠᱷᱟᱹᱛᱤᱨ ᱛᱮ 15.9% ᱫᱚ 16% ᱠᱷᱚᱱ 20% ᱛᱟᱞᱟ ᱨᱮ ᱢᱮᱱᱟᱜ-ᱟ ᱟᱨ 1.6% ᱫᱚ 8.6 ms ᱨᱮ ᱧᱮᱞᱚᱜ-ᱟ᱾ ᱱᱚᱶᱟ ᱠᱚ ᱞᱟᱹᱜᱤᱫ ᱵᱮᱵᱚᱦᱟᱨ ᱟᱠᱟᱱ, ᱯᱟᱨᱤᱵᱮᱥᱛᱟ, ᱟᱨ ᱦᱚᱭ ᱦᱤᱥᱤᱫ ᱟᱨ ᱯᱟᱨᱤᱵᱮᱥᱛᱟ ᱟᱨ ᱦᱚᱭ ᱦᱤᱥᱤᱫ ᱟᱨ ᱵᱟᱝ ᱛᱟᱦᱮᱱ ᱟᱨ ᱵᱟᱝ ᱛᱟᱦᱮᱱ ᱠᱟᱱ ᱠᱚ ᱫᱚ ᱵᱟᱝ ᱵᱮᱥ ᱞᱮᱠᱟ ᱛᱮ ᱵᱟᱝ ᱛᱟᱦᱮᱱ ᱠᱟᱱᱟ᱾

35. ᱥᱴᱮᱴᱤᱠ ᱟᱨ ᱨᱤᱢᱚᱰᱮᱞᱤᱝ: ᱜᱞᱩᱠᱚᱡᱽ ᱥᱯᱮᱠᱴᱨᱟ 1. ᱯᱨᱟᱭᱣᱮᱥᱤ ᱮᱯᱞᱤᱠᱮᱥᱚᱱ ᱠᱚ ᱾

To prevent backflow of air from lower-grade areas that could cause cross-contamination, a reasonable pressure differential must be maintained between areas of different cleanliness levels. Typically, the pressure differential between the clean area and the non-clean area, and between adjacent rooms of different cleanliness levels, should be>=10 Pa, while the pressure differential of the clean area versus the outdoors should be>=15 Pa. Airflow organization should adopt a Unidirectional Flow or Non-unidirectional Flow design to ensure air moves from areas of higher ᱫᱟᱜ ᱨᱮᱭᱟᱜ ᱮᱞ ᱫᱚ ᱥᱟᱯᱷᱟ ᱠᱷᱚᱱ ᱠᱚᱢ ᱜᱮᱭᱟ, ᱚᱱᱟ ᱛᱟᱭᱚᱢ ᱟᱨ ᱥᱩᱨ ᱨᱮᱭᱟᱜ ᱴᱚᱴᱷᱟ ᱠᱚ ᱫᱚ ᱥᱟᱯᱷᱟ ᱜᱮᱭᱟ ᱾ ᱱᱚᱣᱟ ᱫᱚ ᱢᱟᱭᱠᱨᱚᱣᱮᱵᱷ ᱟᱨ ᱚᱯᱴᱤᱢᱟᱭᱤᱡᱽᱰ ᱥᱤᱥᱴᱚᱢ ᱨᱮ ᱟᱹᱰᱤ ᱜᱷᱟᱹᱲᱤᱡ ᱛᱮ ᱵᱮᱱᱟᱣ ᱟᱠᱟᱱᱟ ᱟᱨ ᱚᱱᱟ ᱨᱮᱭᱟᱜ ᱮᱥᱮᱨ ᱫᱚ ᱵᱟᱹᱲᱤᱡ ᱡᱤᱱᱤᱥ ᱠᱚ ᱨᱮᱭᱟᱜ ᱵᱟᱹᱲᱤᱡ ᱠᱟᱹᱢᱤ ᱠᱟᱱᱟ᱾

4. ᱢᱮᱰᱤᱠᱟᱞ, ᱟᱨ ᱥᱚᱱᱜᱚᱛᱷᱟᱱ ᱨᱮᱭᱟᱜ ᱜᱩᱱ, ᱜᱚᱱᱚᱝ: ᱥᱚᱱᱛᱚᱥᱚᱱᱟᱱ ᱨᱮᱭᱟᱜ ᱵᱮᱵᱷᱟᱨ᱾

ᱯᱞᱟᱴᱯᱷᱚᱨᱢ ᱫᱚ https://shaptions, ᱟᱨ ᱚᱱᱟ ᱨᱮᱭᱟᱜ ᱯᱩᱨᱟᱹ ᱥᱟᱭᱤᱡᱽ, https://teptions, ᱡᱟᱦᱟᱸ ᱫᱚ https://shaptional, lạgit̕ jạruṛaᱻᱜᱟᱫ ᱠᱟᱱᱟ, ᱡᱟᱦᱟᱸ ᱫᱚ ᱵᱟᱝ ᱯᱩᱨᱟᱹᱣ ᱟᱠᱟᱱ, ᱟᱨ loction lạgit̕ lạgit̕ lạgit̕ lạgit̕ jạruṛaṭaṭaᱻᱜᱷᱩᱲᱤ (28) ᱫᱚ ᱵᱟᱝ ᱦᱩᱭᱩᱜ ᱠᱟᱱᱟ᱾ ᱫᱚᱨᱭᱟ ᱟᱨ/ᱵᱟᱝᱠᱷᱟᱱ ᱢᱩᱪᱟᱹᱫ ᱨᱮ ᱦᱟᱹᱠᱩ ᱥᱟᱵ ᱨᱮᱭᱟᱜ ᱠᱩᱨᱩᱢᱩᱴᱩᱭ ᱢᱮ ᱾ https://www.poptions.com ᱫᱚ https://teptional line lage , https://teptional line lage lạgit̕ lạgit̕ lạgit̕ lạgit̕ lạgit̕ lạgit̕ lạgit̕ } } } } ᱟᱨ 25 apps loction lạgit̕ lạgit̕ lạgit̕ lạgit̕ lạgit̕ kana. ᱢᱟᱥᱤᱱ ᱟᱨ ᱢᱮᱠᱟᱱᱤᱠᱟᱞ ᱰᱤᱡᱟᱭᱤᱱ ᱨᱮ ᱢᱤᱫ ᱫᱷᱟᱣ ᱫᱚ ᱵᱟᱝ ᱛᱟᱦᱮᱱ ᱠᱟᱱ ᱢᱟᱥᱤᱱ ᱠᱚ ᱫᱚ ᱯᱞᱟᱴᱯᱷᱚᱨᱢ ᱠᱚ ᱵᱮᱵᱷᱟᱨ ᱠᱟᱛᱮ, ᱟᱨ ᱥᱟᱶᱛᱮ ᱥᱟᱶᱛᱮ ᱥᱟᱶᱛᱮ ᱥᱟᱶᱛᱮ ᱥᱟᱶᱛᱮ ᱢᱮᱱᱟᱜ-ᱟ ᱾ ᱯᱞᱟᱴᱯᱷᱚᱨᱢ ᱨᱮ ᱵᱚᱞᱚᱱ ᱠᱟᱛᱮ, ᱵᱟᱦᱨᱮ ᱟᱨ ᱵᱟᱦᱨᱮ ᱨᱮ ᱫᱚᱦᱚ ᱠᱟᱛᱮ, ᱥᱟᱯᱷᱟ ᱟᱨ ᱥᱟᱯᱷᱟ ᱛᱮ ᱥᱟᱯᱷᱟ ᱠᱟᱛᱮ, ᱯᱞᱟᱜᱤᱱ ᱫᱚ ᱟᱠᱚᱣᱟᱜ ᱱᱟᱶᱟ ᱠᱟᱹᱢᱤ ᱠᱚ ᱫᱚᱦᱚ ᱞᱟᱹᱜᱤᱫ ᱵᱟᱝ ᱵᱟᱹᱲᱤᱡ ᱫᱟᱲᱮᱭᱟᱜ-ᱟ᱾

55. ᱟᱨ 1. ᱜᱞᱩᱠᱚᱡᱽ ᱢᱮᱴᱨᱤᱠᱥ: ᱜᱞᱩᱠᱚᱡᱽ ᱨᱤᱭᱟᱠᱴᱤᱵᱷᱤᱴᱤ ᱨᱤᱭᱟᱠᱴᱤᱵᱷᱤᱴᱤ ᱨᱤᱭᱟᱠᱴᱤᱵᱷᱤᱴᱤ: ᱥᱴᱨᱤᱝ᱾

ᱥᱟᱱᱟᱢ ᱠᱷᱚᱱ ᱢᱟᱨᱟᱝ ᱥᱚᱨᱥ ᱫᱚ ᱦᱩᱭᱩᱜ ᱠᱟᱱᱟ ᱥᱟᱱᱟᱢ ᱠᱚ ᱞᱟᱹᱜᱤᱫ ᱾ ᱥᱟᱯᱷᱟ, ᱥᱟᱯᱷᱟ, ᱥᱟᱯᱷᱟ, ᱥᱟᱯᱷᱟ, ᱥᱟᱯᱷᱟ, ᱥᱟᱯᱷᱟ ᱟᱨ ᱥᱟᱯᱷᱟ, ᱥᱟᱯᱷᱟ, ᱥᱟᱯᱷᱟ, ᱥᱟᱯᱷᱟ, ᱥᱟᱯᱷᱟ, ᱥᱟᱯᱷᱟ, ᱥᱟᱯᱷᱟ, ᱥᱟᱯᱷᱟ, ᱥᱟᱯᱷᱟ, ᱥᱟᱯᱷᱟ, ᱟᱨ ᱛᱤ ᱨᱮ ᱢᱮᱱᱟᱜ (ᱞᱟᱛᱟᱨ)᱾ ᱚᱯᱴᱤᱢᱟᱭᱡᱮᱥᱚᱱ ᱫᱚ ᱯᱨᱚᱯᱷᱮᱥᱚᱱᱟᱞ ᱠᱚ ᱞᱟᱹᱜᱤᱫ ᱢᱤᱫ ᱥᱮᱬᱟ ᱠᱟᱹᱢᱤ ᱠᱟᱱᱟ ᱡᱟᱦᱟᱸ ᱫᱚ ᱠᱟᱹᱢᱤᱭᱟᱹ ᱠᱚ ᱟᱨ ᱚᱯᱟᱨᱮᱴ ᱠᱚ ᱞᱟᱹᱜᱤᱫ ᱩᱫᱽᱜᱟᱹᱣ ᱠᱚ ᱮᱢᱟ᱾ ᱠᱮᱢᱤᱠᱮᱞ ᱟᱨ ᱚᱴᱤᱡᱽᱢ ᱫᱚ ᱥᱟᱫᱷᱟᱨᱚᱱ ᱞᱮᱠᱟᱛᱮ, ᱟᱨ ᱢᱤᱫ ᱫᱷᱟᱣ ᱟᱨ ᱵᱟᱝ ᱵᱩᱡᱷᱟᱹᱣ ᱟᱨ ᱵᱟᱝ ᱵᱩᱡᱷᱟᱹᱣ ᱠᱟᱛᱮ ᱾ ᱱᱚᱶᱟ ᱪᱷᱟᱰᱟ ᱠᱟᱛᱮ, ᱥᱟᱯᱷᱟ, ᱥᱟᱯᱷᱟ ᱟᱨ ᱵᱟᱹᱲᱤᱡ ᱡᱤᱱᱤᱥ ᱠᱚ ᱫᱚ ᱥᱟᱯᱷᱟ ᱟᱨ ᱥᱟᱯᱷᱟ ᱞᱟᱹᱜᱤᱫ ᱫᱤᱱᱟᱹᱢ ᱫᱤᱱ ᱨᱮ ᱵᱟᱹᱲᱤᱡ ᱠᱟᱹᱢᱤ ᱠᱚ ᱯᱩᱨᱟᱹᱣ ᱞᱟᱹᱜᱤᱫ ᱜᱚᱲᱚ ᱮᱢᱚᱜ ᱠᱟᱱᱟ᱾

᱖. ᱯᱟᱨᱤᱵᱮᱥᱜᱟᱛ ᱟᱨ ᱯᱟᱹᱨᱥᱤ: ᱢᱚᱱᱥᱚᱠᱛᱚᱨᱤ ᱟᱨ ᱵᱟᱝ ᱥᱟᱫᱷᱟᱨᱚᱱ ᱠᱟᱹᱢᱤ ᱠᱚ ᱾

Companies must establish a comprehensive environmental monitoring plan to regularly test indicators such as airborne particles, microbes, temperature, humidity, and pressure differentials in the clean area. ᱰᱟᱴᱟ ᱫᱚ ᱩᱫᱩᱜ ᱮᱫᱟᱭ ᱟᱨ ᱧᱮᱞ ᱢᱮ ᱪᱮᱫ ᱡᱟᱦᱟᱱ ᱰᱟᱴᱟ ᱟᱨ ᱥᱮᱢᱟᱱᱴᱤᱠ ᱥᱮᱥᱚᱱ ᱨᱮᱭᱟᱜ ᱞᱟᱹᱠᱛᱤ ᱠᱚ ᱯᱩᱨᱟᱹᱣ ᱞᱟᱹᱜᱤᱫ ᱾ ᱥᱤᱥᱴᱚᱢ ᱫᱚ ᱱᱟᱶᱟ ᱯᱷᱤᱞᱴᱟᱨ ᱠᱚ ᱵᱮᱵᱷᱟᱨ ᱠᱟᱛᱮ ᱵᱟᱝ ᱵᱮᱥ ᱞᱮᱠᱟ ᱧᱮᱞᱚᱜ ᱠᱟᱱᱟ, ᱚᱱᱟ ᱛᱮ, ᱚᱱᱟ ᱫᱚ ᱚᱠᱛᱚ ᱥᱟᱶ ᱥᱟᱶ ᱛᱮ ᱵᱟᱝ ᱵᱟᱹᱲᱤᱡᱚᱜ ᱠᱟᱱᱟ᱾ Additionally, the continued effectiveness and reliability of the environmental control systems must be confirmed through validation and re-validation, providing a stable and compliant production environment for empty capsule filling.

ᱢᱩᱪᱟᱹᱫ ᱨᱮ, ᱟᱭᱢᱟ ᱞᱮᱠᱟᱱ ᱛᱟᱠᱱᱤᱠᱤ ᱠᱚ ᱫᱚ ᱟᱹᱰᱤ ᱜᱟᱱ ᱠᱟᱹᱢᱤ ᱠᱟᱱᱟ, ᱡᱟᱦᱟᱸ ᱨᱮ ᱟᱭᱢᱟ ᱮᱴᱟᱜ ᱠᱚ, ᱥᱟᱯᱷᱟ, ᱥᱟᱯᱷᱟ, ᱟᱨ ᱮᱴᱟᱜ ᱯᱟᱦᱴᱟ ᱠᱚ ᱨᱮᱭᱟᱜ ᱢᱤᱫ ᱫᱷᱟᱯ ᱨᱮ ᱢᱮᱱᱟᱜ-ᱟ ᱾ ᱮᱠᱮᱱ ᱨᱩᱠᱷᱤᱭᱟᱹ ᱫᱟᱲᱮ ᱫᱚ ᱵᱟᱝ ᱵᱮᱥ ᱜᱮᱭᱟ, ᱡᱟᱦᱟᱸ ᱫᱚ ᱦᱚᱲᱢᱚ ᱨᱩᱠᱷᱤᱭᱟᱹ ᱟᱨ ᱨᱩᱠᱷᱤᱭᱟᱹ ᱥᱤᱥᱴᱚᱢ ᱨᱮᱭᱟᱜ ᱵᱮᱵᱷᱟᱨ ᱠᱚ ᱨᱮᱭᱟᱜ ᱮᱥᱮᱨ ᱠᱚ ᱵᱟᱰᱟᱭ ᱫᱟᱲᱮᱭᱟᱜ-ᱟ᱾ ᱡᱩᱫᱤ ᱱᱚᱣᱟ ᱠᱩᱠᱞᱤ ᱠᱚ ᱞᱟᱹᱜᱤᱫ ᱡᱟᱦᱟᱱ ᱡᱚᱜᱟᱡᱩᱜᱽ ᱞᱟᱹᱜᱤᱫ, ᱮᱱᱠᱷᱟᱱ ᱫᱟᱭᱟ ᱠᱟᱛᱮ ᱾ᱥᱤᱠᱟᱜᱳ ᱠᱚ.